ClinicalTrials.gg
Not yet recruitingNCT07798154SBA-APRVUpdated Sep 1, 2026

Effect of Spontaneous Breathing in APRV Mode on Respiratory Physiology of ARDS Patients

An interventional study of APRV ventilation with low-level spontaneous breathing and APRV ventilation with high-level spontaneous breathing in Acute Respiratory Distress Syndrome, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 146 studies in Respiratory Distress Syndrome with a site in China — 54 open to participants now, 55 under way, 6 of them phase 3. Respiratory Distress Syndrome · China.

Planned enrollment
76th of 81
15 · median 100
Started
2026
with 13 others
No phase
52 of 146
21 open now
Primary completion
2026-11
later than 26 of 54 live
Registered
143rd of 146
by date
Lead sponsor
3 of 146
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Among the 146 studies in Respiratory Distress Syndrome with a site in China, this one is the 76th largest by planned enrollment of the 81 interventional ones that give a count, is one of 14 that started in 2026, is one of 52 with no phase, reaches primary completion later than 26 of the 54 other live ones, and was the 143rd registered.

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 282 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Open to participants now

54 of the 146 studies in Respiratory Distress Syndrome with a site in China are open now. Recruiting first, the newest first:

49 more — sign in →

All 54 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 193 Respiratory Distress Syndrome studies recruiting now, 117 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 50 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

This is a single-center, prospective, randomized, three-period crossover physiological study in adult patients with moderate-to-severe acute respiratory distress syndrome (ARDS, PaO₂/FiO₂ ≤150 mmHg). Each enrolled subject will receive all three APRV ventilation conditions in random sequence: low-level spontaneous breathing (spontaneous minute-ventilation proportion 10%-30%), high-level spontaneous breathing (31%-50%), and fully suppressed spontaneous breathing as control. A 30-minute wash-out period is set between each condition to restore unified physiological baseline. Primary outcome is ventilation-perfusion mismatch percentage (mismatch%) measured by Electrical Impedance Tomography (EIT). Secondary outcomes include EIT-derived pulmonary parameters, respiratory mechanics, hemodynamics, diaphragmatic function and safety profiles. Only short-term, reversible ventilator and sedation adjustments will be performed; routine clinical management remains unchanged throughout the trial.

Read the detailed description

Acute respiratory distress syndrome (ARDS) is a life-threatening critical respiratory illness characterized by heterogeneous pulmonary injury and severe ventilation-perfusion mismatch. Airway Pressure Release Ventilation (APRV) permits spontaneous breathing throughout the whole respiratory cycle, which may improve regional ventilation-perfusion matching and hemodynamic status. Nevertheless, excessive spontaneous breathing effort may trigger pendelluft phenomenon, augment regional lung strain and precipitate patient-self-inflicted lung injury (P-SILI). To date, the safe intensity range of spontaneous breathing during APRV for moderate-to-severe ARDS patients has not been well defined.

This single-center, randomized 3-period crossover self-controlled physiological trial enrolls ICU adult patients aged 18-80 years, diagnosed with moderate-to-severe ARDS (PaO₂/FiO₂ ≤ 150 mmHg) within 48-hours of invasive mechanical ventilation. After written informed consent obtained from legal surrogates, subjects will first receive a 60-minute baseline ventilation period following ARDSnet low-tidal-volume pressure-control ventilation strategy under deep sedation without spontaneous breathing. Subsequently, every participant will undergo three APRV intervention states in computer-generated random order: Condition A: APRV with low-intensity spontaneous breathing (spontaneous-contributed minute ventilation 10%-30%); Condition B: APRV with high-intensity spontaneous breathing (31%-50%); Condition C: APRV with fully suppressed spontaneous breathing via deep sedation (RASS -4 to -5). Each intervention maintains target spontaneous-breathing intensity for 30-minute stabilization before data collection. A mandatory 30-minute wash-out phase will be implemented between successive interventions to revert subjects back to baseline pressure-control ventilation and sedation status.

Primary endpoint is the comparison of ventilation-perfusion mismatch percentage (mismatch%, calculated as sum of dead-space fraction and shunt fraction) among three states measured by bedside EIT. Secondary endpoints contain multiple EIT quantitative indices, respiratory mechanics parameters (including esophageal-pressure-derived transpulmonary pressure), hemodynamic and right-ventricular function, diaphragmatic ultrasound indices, arterial blood gas variables. Adverse events related to respiratory, circulatory and operational procedures are closely monitored as safety outcomes.

Planned sample size is 14-16 enrolled participants to achieve 12 evaluable subjects completing all three intervention sequences considering dropout rate. All ventilator and sedation modifications are short-term and reversible; standard clinical therapeutic regimens will not be altered except for study-related procedures. After finishing all three intervention periods, ventilator and sedation settings will be returned to clinical team's discretion. Linear mixed-effect models will be applied for statistical analysis of crossover-design data.

03

Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • Airway Pressure Release Ventilation
  • spontaneous breathing
  • electrical impedance tomography
  • ventilation-perfusion mismatch
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Age ≥18 and ≤80 years old. 2. Diagnosed with moderate-to-severe ARDS according to the 2023 global ARDS definition.

    3. Within 48 hours of invasive mechanical ventilation. After 1-hour low-tidal-volume pressure-controlled ventilation following ARDSnet strategy, arterial blood gas shows PaO₂/FiO₂ ≤ 150 mmHg.

    4. Written is obtained from the patient or their legal surrogate decision-maker after full explanation of the study by the principal investigator or authorized study physician.

Exclusion criteria

Exclusion Criteria:

  • 1. shock defined as persistent hyperlactatemia and/or prolonged capillary refill time, fluid-resistant, requiring norepinephrine ≥ 0.5 μg/kg/min.

    2. Severe chronic medical conditions severely affecting cardiopulmonary function: severe , interstitial lung disease, pulmonary embolism, right-heart failure, pulmonary hypertension, or severe arrhythmia.

    3. Radiologically confirmed bronchopleural fistula, status post lobectomy, or other major thoracic surgery.

    4. to electrical impedance tomography (EIT): extensive chest skin injury or infection, implanted cardiac pacemaker or defibrillator, etc.

    5. Contraindications for esophageal manometry placement: esophageal obstruction, perforation, severe esophageal varices, etc.

    6. Diaphragmatic hernia, severe chest wall deformity, or significant pulmonary bullae.

    7. Significant coagulation abnormalities (PT or prolonged ≥2 times , or INR>2.0) with active bleeding risk.

    8. Severe intracranial hypertension (>20 mmHg), severe traumatic brain injury (GCS ≤8), or neuromuscular disorders.

    9. Pregnant or breastfeeding women. 10. Patients already receiving ECMO therapy. 11. Expected survival time \<24 hours judged by attending physician. 12. (BMI) >35 kg/m². 13. Previously enrolled in this study or participating in other interventional clinical trials.

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Low-level spontaneous breathing under APRV

    APRV ventilation with spontaneous-contributed minute-ventilation proportion maintained at 10%-30%. A stabilization period of 30 minutes is performed before data collection

    Device: APRV ventilation with low-level spontaneous breathing

  • Experimental
    High-level spontaneous breathing under APRV

    APRV ventilation with spontaneous-contributed minute-ventilation proportion maintained at 31%-50%. A stabilization period of 30 minutes is performed before data collection.

    Device: APRV ventilation with high-level spontaneous breathing

  • Experimental
    Fully suppressed spontaneous breathing under APRV

    APRV ventilation with spontaneous breathing completely suppressed by deep sedation (RASS-4 to -5). A stabilization period of 30 minutes is performed before data collection.

    Device: APRV ventilation with fully suppressed spontaneous breathing

Interventions

  • DeviceAPRV ventilation with low-level spontaneous breathing

    APRV ventilation mode, spontaneous-contributed minute-ventilation proportion maintained at 10%-30%. 30-minute stabilization before outcome measurement.

  • DeviceAPRV ventilation with high-level spontaneous breathing

    APRV ventilation mode, spontaneous-contributed minute-ventilation proportion maintained at 31%-50%. 30-minute stabilization before outcome measurement.

  • DeviceAPRV ventilation with fully suppressed spontaneous breathing

    APRV ventilation mode, spontaneous breathing fully suppressed by deep sedation (RASS-4 to -5). 30-minute stabilization before outcome measurement.

06

What researchers measure

Primary outcomes

  1. Ventilation-perfusion mismatch percentage (Mismatch%)

    Ventilation-perfusion mismatch percentage (Mismatch%), calculated as the sum of dead-space percentage and shunt percentage measured by electrical impedance tomography (EIT). A composite index reflecting overall ventilation-perfusion mismatch, assessed at baseline and under three APRV experimental conditions. Unit: %

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

Secondary outcomes

  1. Match percentage(match%)

    Match percentage derived from electrical impedance tomography (EIT). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  2. Pendelluft amplitude

    Pendelluft amplitude derived from electrical impedance tomography (EIT). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  3. Dead-space percentage

    Dead-space percentage derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  4. Shunt percentage

    Intrapulmonary shunt percentage derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  5. Global inhomogeneity index (GI)

    Global inhomogeneity index (GI) derived from electrical impedance tomography (EIT). Unit: unitless.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period

  6. Center of ventilation (CoV)

    Center of ventilation (CoV) derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  7. Tidal recruitment-derecruitment

    Tidal recruitment-derecruitment (Tidal R/D) derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  8. Ventilation distribution

    Regional ventilation distribution derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  9. Perfusion distribution

    Regional pulmonary perfusion distribution derived from electrical impedance tomography (EIT), assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  10. Peak airway pressure (Ppeak)

    Airway peak pressure (Ppeak) measured by mechanical ventilator, assessed at baseline and under three APRV experimental conditions. Unit: cmH₂O

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  11. Plateau pressure (Pplat)

    Airway plateau pressure (Pplat) obtained from end-inspiratory hold maneuver, assessed at baseline and under three APRV experimental conditions. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  12. Driving pressure (ΔP)

    Driving pressure (ΔP) derived from mechanical ventilator measurements. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  13. Static respiratory system compliance (Cstat)

    Static respiratory system compliance (Cstat), assessed at baseline and under three APRV experimental conditions. Unit: mL/cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  14. End-inspiratory esophageal pressure (PesI)

    End-inspiratory esophageal pressure (PesI) measured by esophageal manometry, assessed at baseline and under three APRV experimental conditions. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  15. End-expiratory esophageal pressure (PesE)

    End-expiratory esophageal pressure (PesE) measured by esophageal manometry, assessed at baseline and under three APRV experimental conditions. Unit: cmH₂O

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  16. Esophageal pressure swing (ΔPes)

    Esophageal pressure swing (ΔPes) measured by esophageal manometry, assessed at baseline and under three APRV experimental conditions. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  17. End-inspiratory transpulmonary pressure (PtpI)

    End-inspiratory transpulmonary pressure (PtpI) derived from airway and esophageal pressure measurements. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  18. Transpulmonary driving pressure (ΔPtp)

    Transpulmonary driving pressure (ΔPtp) derived from airway and esophageal pressure measurements. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  19. End-expiratory transpulmonary pressure (PtpE)

    End-expiratory transpulmonary pressure (PtpE) derived from airway and esophageal pressure, assessed at baseline and under three APRV experimental conditions. Unit: cmH₂O.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  20. Esophageal pressure-time product per minute (PTPes/min)

    Esophageal pressure-time product per minute (PTPes/min) read directly from the ventilator interface. Unit: cmH₂O·s/min.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  21. Dynamic transpulmonary driving pressure (ΔPL,dyn)

    Dynamic transpulmonary driving pressure (ΔPL,dyn) obtained from ventilator measurements; only measured in the presence of spontaneous breathing effort. Unit: cmH₂O.

    Time frame: At the end of each 30-minute APRV experimental condition (after stabilization)

  22. Inspiratory muscle pressure (Pmus)

    Inspiratory muscle pressure (Pmus) obtained from ventilator measurements; only measured in the presence of spontaneous breathing effort. Unit: cmH₂O

    Time frame: At the end of each 30-minute APRV experimental condition (after stabilization)

  23. End-expiratory occlusion pressure (ΔPocc)

    End-expiratory occlusion pressure (ΔPocc) obtained from ventilator measurements; only measured in the presence of spontaneous breathing effort. Unit: cmH₂O

    Time frame: At the end of each 30-minute APRV experimental condition (after stabilization)

  24. Airway occlusion pressure (P0.1)

    Airway occlusion pressure (P0.1) obtained from ventilator measurements; only measured in the presence of spontaneous breathing effort. Unit: cmH₂O

    Time frame: At the end of each 30-minute APRV experimental condition (after stabilization)

  25. Muscular pressure index (PMI)

    Muscular pressure index (PMI) obtained from ventilator measurements; only measured in the presence of spontaneous breathing effort. Unit: cmH₂O

    Time frame: At the end of each 30-minute APRV experimental condition (after stabilization)

  26. Negative inspiratory force (NIF)

    Negative inspiratory force (NIF) obtained from ventilator measurements; only measured in the presence of spontaneous breathing effort. Unit: cmH₂O

    Time frame: At the end of each 30-minute APRV experimental condition (after stabilization)

  27. Heart rate

    Heart rate from continuous bedside monitoring, assessed at baseline and under three APRV experimental conditions. Unit: beats per minute.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  28. Mean arterial pressure (MAP)

    Mean arterial pressure (MAP) measured via invasive arterial catheter, assessed at baseline and under three APRV experimental conditions. Unit: mmHg.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  29. Vasopressor dosage (μg/kg/min)

    Dosage of vasoactive medications, assessed at baseline and under three APRV experimental conditions. Unit: μg/kg/min

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  30. Central venous pressure (CVP)

    Central venous pressure (CVP), assessed at baseline and under three APRV experimental conditions. Unit: mmHg.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  31. Right-ventricular fractional area change

    Right-ventricular fractional area change measured by transthoracic echocardiography, assessed at baseline and under three APRV experimental conditions. Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  32. Velocity-time-integral (VTI)

    Velocity-time-integral (VTI) measured by transthoracic echocardiography, assessed at baseline and under three APRV experimental conditions. Unit: cm.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  33. Tricuspid annular plane systolic excursion (TAPSE)

    Tricuspid annular plane systolic excursion (TAPSE) measured by transthoracic echocardiography, assessed at baseline and under three APRV experimental conditions. Unit: mm.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  34. Cardiac output (CO)

    Cardiac output (CO) calculated from velocity-time integral (VTI) measured by transthoracic echocardiography, assessed at baseline and under three APRV experimental conditions. Unit: L/min.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  35. Stroke volume (SV)

    Stroke volume (SV) calculated from velocity-time-integral (VTI) measured by transthoracic echocardiography, assessed at baseline and under three APRV experimental conditions. Unit: mL.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  36. Diaphragm displacement

    Diaphragm displacement measured by bedside diaphragm ultrasound, assessed in two out of the three APRV experimental conditions only when spontaneous breathing was present. Unit: mm.

    Time frame: At the end of 30-minute APRV experimental conditions with spontaneous breathing effort (after stabilization)

  37. Diaphragm thickening fraction

    Diaphragm thickening fraction measured by bedside diaphragm ultrasound, assessed in two out of the three APRV experimental conditions only when spontaneous breathing was present. Unit: %.

    Time frame: At the end of 30-minute APRV experimental conditions with spontaneous breathing effort (after stabilization)

  38. Lung 12-zone ultrasound score

    Lung ultrasound score based on 12-zone lung ultrasound assessment, assessed at baseline and under three APRV experimental conditions. Unit: unitless.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  39. Overdistension (OD) pixel count

    Pixel count of lung overdistension (OD), exported directly from electrical impedance tomography (EIT) software basic module, averaged over complete respiratory cycles within selected time interval, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: pixels.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  40. Overdistension (OD) proportion

    Proportion of lung overdistension (OD) relative to total lung-region pixels, exported directly from electrical impedance tomography (EIT) software basic module, averaged over complete respiratory cycles within selected time interval, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  41. Recruitment (CR) pixel count

    Pixel count of lung recruitment (CR), exported directly from electrical impedance tomography (EIT) software basic module, averaged over complete respiratory cycles within selected time interval, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: pixels.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  42. Recruitment (CR) proportion

    Proportion of lung recruitment (CR) relative to total lung-region pixels, exported directly from electrical impedance tomography (EIT) software basic module, averaged over complete respiratory cycles within selected time interval, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  43. Atelectasis (AT) pixel count

    Pixel count of lung atelectasis (AT), exported directly from electrical impedance tomography (EIT) software basic module, averaged over complete respiratory cycles within selected time interval, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: pixels.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  44. Atelectasis (AT) proportion

    Proportion of lung atelectasis (AT) relative to total lung-region pixels, exported directly from electrical impedance tomography (EIT) software basic module, averaged over complete respiratory cycles within selected time interval, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

Other outcomes

  1. Incidence and severity of adverse events

    Incidence and severity of adverse events during study interventions, focusing on respiratory events, circulatory events and procedure-related adverse events. Unit: unitless.

    Time frame: During each APRV experimental intervention period

  2. Rate of premature intervention discontinuation for safety concerns

    Rate of premature discontinuation of study interventions due to safety-related reasons. Unit: %.

    Time frame: During each APRV experimental intervention period

  3. Inspired oxygen fraction (FiO₂)

    Set inspired oxygen fraction, obtained directly from ventilator readings, recorded at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  4. Arterial pH

    Arterial blood pH measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: unitless.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  5. Arterial partial pressure of oxygen (PaO₂)

    Arterial partial pressure of oxygen measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: mmHg.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  6. Arterial partial pressure of carbon dioxide (PaCO₂)

    Arterial partial pressure of carbon dioxide measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: mmHg.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  7. Arterial oxygen saturation (SaO₂)

    Arterial oxygen saturation measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: %.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  8. Bicarbonate (HCO₃-)

    Serum bicarbonate (HCO₃-) measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: mmol/L.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  9. Base excess (BE)

    Base excess (BE) measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: mmol/L.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  10. Arterial lactate (Lac)

    Arterial lactate (Lac) measured from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: mmol/L.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  11. PaO₂/FiO₂ ratio

    PaO₂/FiO₂ ratio calculated from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: unitless.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  12. Alveolar-arterial oxygen difference (A-aDO₂)

    Alveolar-arterial oxygen difference calculated from arterial blood gas analysis, measured at baseline (prior to intervention, after stabilization) and at the end of each 30-minute APRV experimental condition (after stabilization). Unit: mmHg.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  13. Correlation analysis among multiple respiratory-hemodynamic-diaphragm parameters

    Explore the correlations among EIT parameters, respiratory mechanics, blood gas analysis, hemodynamics and diaphragm function across three study conditions.

    Time frame: Corresponding study time points

  14. Ventilatory ratio (VR)

    Ventilatory ratio (VR), a calculated index reflecting pulmonary dead-space and lung injury severity, is computed from minute ventilation and arterial CO₂ values assessed at baseline and under three APRV experimental conditions. Unit: unitless.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  15. Expired tidal volume (VTe)

    Expired tidal volume assessed at baseline and under three APRV experimental conditions. Unit: mL.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  16. Total respiratory rate

    Total respiratory rate assessed at baseline and under three APRV experimental conditions. Unit: breaths/min.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  17. Total minute ventilation

    Total minute ventilation assessed at baseline and under three APRV experimental conditions. Unit: L/min.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

  18. Spontaneous minute ventilation

    Spontaneous component of minute ventilation assessed under two APRV experimental conditions only when spontaneous breathing was present, derived directly from ventilator readings. Unit: L/min.

    Time frame: At the end of 30-minute APRV experimental conditions with spontaneous breathing effort (after stabilization)

  19. Proportion of spontaneous minute ventilation

    Proportion of spontaneous minute ventilation relative to total minute ventilation, calculated under two APRV experimental conditions only when spontaneous breathing was present. Unit: %.

    Time frame: At the end of 30-minute APRV experimental conditions with spontaneous breathing effort (after stabilization)

  20. Mechanical power (MP)

    Mechanical power of ventilation as an indicator of ventilator-induced lung injury (VILI) risk, obtained directly from ventilator readings at baseline and under three APRV experimental conditions. Unit: J/min.

    Time frame: Baseline and at the end of each 30-minute experimental condition during the study intervention period.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.

Of 264 non-industry interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 1 month is below that.

Counting every sponsor, half of 271 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Sep 1, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07798154
Responsible party
XiaoJing Zou,MD (Chief Physician, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Sep 1, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 1, 2026

Study contacts

Xiaojing Zou
Contact
249126734@qq.com
+86-27-85351606
xiaojing zou, MD
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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