Actively Recruiting
End-expiratory Transpulmonary Pressure-guided vs EIT-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study
Led by XiaoJing Zou,MD · Updated on 2025-11-21
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods of adjusting positive end-expiratory pressure (PEEP) in patients with intra-abdominal hypertension (IAH) and acute respiratory distress syndrome (ARDS). This randomized crossover study compares the effects of end-expiratory transpulmonary pressure-guided PEEP titration and electrical impedance tomography (EIT)-guided PEEP titration on lung ventilation, shunt, dead space, and ventilation-perfusion ratio. The study aims to find an optimal PEEP titration strategy that maintains lung recruitment while minimizing lung injury and avoiding harm to other organs, with potential benefits for a wider patient population. The study involves two experimental interventions. One uses transpulmonary pressure guidance where after baseline ventilation and lung recruitment, the ventilator is set to volume-controlled mode with PEEP adjusted to keep end-expiratory transpulmonary pressure above zero and end-inspiratory pressure below 20 cmH2O. The other uses EIT guidance where the ventilator is set to pressure-controlled mode with pressure control at 15 cmH2O; PEEP starts at 35 cmH2O and is decreased in steps of 3 cmH2O every 2 minutes down to 2 cmH2O using the ODCL method. Participants will undergo these PEEP titrations with monitoring by electrical impedance tomography, respiratory and hemodynamic assessments, and measurement of gas exchange and mechanical power. Researchers will measure differences in optimal PEEP levels between methods and evaluate lung ventilation homogeneity, shunt fraction, and ventilation-perfusion matching. The study includes single masking and randomized allocation, with the primary outcome assessed after PEEP titration. Participation may last through the ventilation phases and monitoring periods as outlined by the protocol.
CONDITIONS
Brief Title
End-expiratory Transpulmonary Pressure-guided vs Electrical Impedance Tomography-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Intra-abdominal hypertension with pressure of 12 mmHg or higher
- Diagnosis of acute respiratory distress syndrome (ARDS) based on the 2023 global definition
- PaO2/FiO2 ratio of 150 or less
- Within 36 hours of starting invasive mechanical ventilation
- Signed informed consent given by patient or family member
You will not qualify if you...
- Age below 18 years or above 80 years
- Uncorrected shock of any type
- Chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia
- Pneumothorax, bronchopleural fistula, recent lung surgery within 2 weeks
- Use of non-invasive ventilation or high-flow nasal oxygen
- Contraindications to electrical impedance tomography (EIT) such as large chest skin injuries, infections, pacemaker or defibrillator implants, pneumothorax, mediastinal emphysema, or massive pleural effusion
- Esophageal obstruction, perforation, severe bleeding, or recent upper gastrointestinal surgery preventing esophageal pressure catheter placement
- Diaphragmatic hernia, thoracic deformity, or obvious pulmonary hernias
- Prolonged coagulation times or active bleeding in the nasopharynx
- Severe neurological disease including intracranial hypertension or neuromuscular disease
- Pregnant or breastfeeding women
- Patients scheduled for extracorporeal membrane oxygenation (ECMO) treatment
- Re-admission to ICU if previously included or participation in other clinical studies
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session with crossover between methods
Participants undergo two different PEEP titration methods while receiving invasive mechanical ventilation for acute respiratory distress syndrome with intra-abdominal hypertension. Each method involves ventilator adjustments and monitoring to determine optimal PEEP settings.
1 treatment visit including both PEEP titration methods in sequence
Duration - 30 minutes
Participants are monitored for respiratory and hemodynamic parameters for 30 minutes after PEEP titration to assess clinical outcomes.
1 post-treatment monitoring visit
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
X
Xiaojing Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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