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CompletedNCT06808438ARDS,PEEPUpdated Aug 26, 2026

Incremental and Decremental PEEP Titration by Diverse Strategies in Subjects With ARDS: A Prospective Physiological Study

An observational study in ARDS, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by West China Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
31
Ages
18 Years and older
Sex
All
01

Study summary

The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of this study was to explore and uncover the physiological differences in response to optimal PEEP in different ways,and analyzed the correlation of the optimal PEEP in these different ways.

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Conditions studied

  • ARDS
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In context

Lead sponsor

West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

ntubated and mechanical ventilated patients over 18 years with moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg) admitted to the ICU within 48 hours were enrolled from October 2022 to July 2024.

Inclusion criteria

  • Intubated and mechanical ventilated patients in ICU within 48 hours
  • Be over 18 years old
  • With moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg)

Exclusion criteria

Exclusion Criteria:

  • Severe chronic obstructive pulmonary diseases
  • Pulmonary bulla(>1CM) or pneumothorax or pneumomediastinum or subcutaneous emphysema
  • Pregnancy
  • BMI≥35kg/m2
  • Suspected pulmonary vascular hemorrhage
  • Disturbance of consciousness or intracranial hypertension
  • Severe cardiac dysfunction (New York Heart Association Class III or IV, acute -Coronary syndrome or persistent ventricular tachyarrhythmia), cardiogenic shock or after major cardiac surgery
  • Hemodynamic instability (i.e., mean arterial pressure [MAP]\<60 mm Hg despite vasopressor use
  • The medical team considering short periods of high pressure to be unsafe
  • Contraindications for placement of esophageal pressure catheters (e.g., esophageal varix or fracture of skull base)
  • Contraindications for EIT monitoring (including pacemaker, or cutaneous diseases which limiting electrode placement)
  • Agonal stage or end-stages of diseases
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
31 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • DeviceEsophageal pressure catheter

    Esophageal pressure was monitored with an esophageal pressure catheter

06

What researchers measure

Primary outcomes

  1. the selected PEEP values

    1\. Method-specific selected PEEP values * Description: The principal endpoint was the set of 15 method-specific selected PEEP values determined for each patient. * Unit of Measure: cmH₂O

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. SpO2/FiO2 at each selected PEEP

    SpO2/FiO2 measured at each selected PEEP. This study will separately measure peripheral oxygen saturation (SpO₂, unit: %) and fraction of inspired oxygen (FiO₂, unit: %). Because both measurements share the same unit (%), they will not be reported as separate outcome measures. Instead, they will be aggregated into a single reported value: the SpO₂/FiO₂ ratio (dimensionless). At each selected positive end-expiratory pressure (PEEP) level, the ratio will be calculated as S/F = SpO₂ (%) ÷ FiO₂ (%), and this ratio will be recorded as the final outcome measure.

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  2. respiratory system compliance value at each selected PEEP

    This study will directly record the respiratory system compliance value as measured and displayed by the ventilator (unit: mL/cmH₂O) at each selected PEEP.

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  3. plateau pressure at each selected PEEP

    At each selected positive end-expiratory pressure (PEEP) level, plateau pressure will be directly recorded from the ventilator after performing an inspiratory hold maneuver. This value is displayed by the ventilator in cmH₂O

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  4. Driving Pressure at each selected PEEP

    At each selected positive end-expiratory pressure (PEEP) level, plateau pressure (Pplat, unit: cmH₂O) will be measured via the ventilator, and the corresponding PEEP value (unit: cmH₂O) will be recorded. Driving pressure (ΔP) is calculated as the difference between the two: ΔP = Pplat - PEEP (unit: cmH₂O).

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  5. End-inspiratory Transpulmonary Pressure (PTPi) at each selected PEEP

    After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-inspiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPi) is calculated as the difference between the airway plateau pressure (Pplat) measured during the hold and the corresponding esophageal pressure (Pes): PTPi = Pplat - Pes (unit: cmH₂O).

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  6. End-expiratory Transpulmonary Pressure (PTPe) at each selected PEEP

    After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-expiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPe) is calculated as the difference between the PEEP measured during the hold and the corresponding esophageal pressure (Pes): PTPe = PEEP - Pes (unit: cmH₂O). This calculated value is the single reported outcome measure

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  7. transpulmonary driving pressure at each selected PEEP

    After placement of an esophageal pressure catheter, the ventilator will monitor transpulmonary pressures. At each selected PEEP level, end-inspiratory transpulmonary pressure (PTPi) and end-expiratory transpulmonary pressure (PTPe) are obtained during inspiratory and expiratory hold maneuvers, respectively. Both are measured in cmH₂O. Transpulmonary driving pressure is calculated as the difference: ΔPtp = PTPi - PTPe (unit: cmH₂O).

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  8. EIT-derived Regional Ventilation Parameters at each selected PEEP level

    Using electrical impedance tomography (EIT), the lung is divided into four regions of interest (ROI I to ROI IV) from ventral to dorsal. For each ROI, the percentage of tidal impedance variation relative to total tidal impedance variation is recorded (% of total). unit: cmH₂O

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  9. the center of ventilation (COV) at each selected PEEP level

    the center of ventilation (COV) is calculated as the position of the ventilation center along the ventral-dorsal axis, expressed as a percentage (0% = ventral, 100% = dorsal). this parameter is measured in %

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  10. CL HP% (overdistension region) at each selected PEEP level

    Using electrical impedance tomography (EIT),based on regional compliance analysis,CL HP% represent the percentage of lung regions showing a decrease in compliance at high PEEP due to overdistension (unit: %).

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

  11. CL LP% (collapse region) at selected PEEP

    Using electrical impedance tomography (EIT),based on regional compliance analysis,CL LP% represent the percentage of lung regions showing a decrease in compliance at low PEEP due to collapse (unit: %).

    Time frame: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

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Study locations

1 site
  • West China Hospital of Sichuan University, Chengdu
    Chengdu, Sichuan 610041, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06808438
Lead sponsor
West China Hospital
Responsible party
Zhou Yongfang (Chief respiratory therapist, Sichuan University) — Principal investigator
First posted
Feb 5, 2025
Start date
Dec 10, 2024
Primary completion
Jul 28, 2025
Completion
Jul 28, 2025
Last update
Aug 26, 2026

Oversight

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

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