Actively Recruiting
Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
Led by University General Hospital of Patras · Updated on 2026-02-11
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different types of perioperative mechanical ventilation (MV) to see which better prevents postoperative pulmonary complications (PPCs) in adult patients at higher risk. The study compares Protective Mechanical Ventilation (PMV), a conventional method with preset lung pressures, to MV using the lowest possible Driving Pressure (ΔP) tailored to individual lung mechanics. The goal is to find if MV with lower ΔP can reduce PPCs, hospital stay length, ICU need, and mortality. Participants will be randomly assigned to one of two groups. One group receives conventional PMV with standard settings including PEEP of 8 cm H2O and tidal volume of 8 ml/kg ideal body weight. The other group receives MV where PEEP is individually adjusted to minimize driving pressure after measuring lung compliance. Both groups receive mechanical ventilation with similar volumes, respiratory rates, inspired oxygen fractions, and hourly recruitment maneuvers during surgery. After surgery, participants will be monitored for PPCs such as atelectasis, respiratory failure, bronchospasm, pleural effusion, pneumonia, aspiration pneumonitis, and pneumothorax using arterial blood tests and chest X-rays. Researchers will also record hospital stay duration, ICU admission and stay, 28-day mortality, and detailed perioperative lung pressure and volume measurements. The study follows patients from the operation day through their hospital stay and up to 28 days postoperatively.
CONDITIONS
Brief Title
Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 17 years
- Undergoing surgery with general anesthesia and invasive mechanical ventilation
- Preoperative ARISCAT score greater than 25 indicating higher risk for pulmonary complications
You will not qualify if you...
- Age less than 18 years
- Preoperative ARISCAT score less than 26
- Women who are pregnant or have recently given birth
- Receiving anesthesia other than general anesthesia
- Contraindications to neuromuscular blockade agents
- Contraindications to stopping spontaneous breathing
- Mechanical ventilation without endotracheal intubation
- Severe heart failure or severe cardiac arrhythmia
- Severe emphysematous lung disease
- Patient refusal to participate in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery and mechanical ventilation
Participants undergo surgery with general anesthesia and receive invasive mechanical ventilation using either conventional lung protective ventilation or PEEP titration for minimum driving pressure during the operation.
1 visit (in-person) during surgery
Duration - Up to 28 days after surgery
Participants are monitored for postoperative pulmonary complications and other clinical outcomes from immediately after surgery until discharge or up to 28 days.
Approximately daily visits while hospitalized
Trial Site Locations
Total: 1 location
1
University Hospital of Patras
Pátrai, Greece, 26504
Actively Recruiting
Research Team
A
Antonios D Kostouros, Resident
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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