The effect of driving pressure-guided positive end-expiratory pressure on postoperative pulmonary complication in patients undergoing major surgery under pneumoperitoneum: a randomized controlled trial

Not Applicable

Recruiting

• Conditions: Diseases of the respiratory system

• Registration Number: KCT0004888
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-09
• Last Update Posted: 8 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

Patients who are 18 years of age or older and who undergo major surgery under pneumoperitoneum with Trendelenburg position, who have a moderate or higher risk of developing postoperative pulmonary complications were included.

Exclusion Criteria

1) open surgery
2) American Society of Anesthesiologists physical status classification = 3
3) in case of patients with acute respiratory distress syndrome before surgery or patients with history of acute respiratory distress syndrome
4) body mass index = 35 kg/m2
5) in case of patients with angina, heart failure or suspicion of increased intracranial pressure
6) in case of patients with pneumothorax or giant bullae
7) other contraindications for applying positive end-expiratory pressure (bronchopleural fistula, hypovolemic shock, right ventricular failure, etc)
8) pregnant woman
9) surgery performed at the prone position, lateral position, or reverse Trendelenburg position

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of postoperative pulmonary complications (atelectasis, SpO2 = 92%(room air), acute respiratory distress syndrome, pneumonia, pleural effusion, bronchospasm, pneumothorax, aspiration pneumonia, early extubation failure or requirement of reintubation, postoperative requirements for rescue maneuvers)

Secondary Outcome Measures

Name	Time	Method
arterial blood gas analysis;other postoperative complications (heart failure, wound infection, wound dehiscence, sepsis, acute kidney injury [determined by Kidney Disease Improving Global Outcomes{KDIGO} creatinine criteria], surgical reintervention, etc);clinical outcome (length of hospital stay, intensive care unit admission, length of intensive care unit stay);respiratory variables during intraoperative mechanical ventilation