An observational study in Respiratory Distress Syndrome, Positive-Pressure Respiration and Mechanical Ventilation, sponsored by Zhongda Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Zhongda Hospital · Observational
This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.
Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability.
Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows:
Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team.
To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters.
EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%).
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Zhongda Hospital is the lead sponsor of 104 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Intubated mechanically ventilated ARDS patients.
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Exclusion Criteria:
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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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ventilation-perfusion matching (V/Q match%)
corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused
Time frame: Through study completion (within 24 hours)
percentage of dead space
corresponding to the ventilated but nonperfused pixels divided by the total number of pixels ventilated and/or perfused
Time frame: Through study completion (within 24 hours)
percentage of shunt
corresponding to the perfused but nonventilated pixels divided by the total number of pixels ventilated and/or perfused
Time frame: Through study completion (within 24 hours)
Respiratory system compliance
The compliance of respiratory system
Time frame: Through study completion (within 24 hours)
PaO2/FiO2 ratio
PaO2/FiO2 ratio
Time frame: Through study completion (within 24 hours)
Plan to share: No
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