Clinical trial NCT06181279: Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity
Official title: Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Atelectasis
Obesity, Morbid
Keywords: Individual Positive End-expiratory Pressure
Driving Pressure
Ventilator-induced Lung Injury
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.

Detailed description: Positive end-expiratory pressure (PEEP) is a strategy that helps to keep alveoli open during surgery and to prevent postoperative atelectasis. A fixed PEEP without considering the respiratory mechanics in individual patients, however, is not optimal. Individualized PEEP therefore has been increasingly studied, and has been shown to improve oxygenation in both nonobese and obese patients. Studies have shown that the occurrence and prognosis of PPCs are significantly associated with high driving pressure (DP), but not with VT and PEEP. Driving pressure-guided individualized PEEP is expected to be a novel perioperative lung protection strategy. Consequently, the main aim of this study is to investigate the effect of a driving pressure-guided individualized PEEP ventilation strategy on postoperative pulmonary atelectasis in morbidly obese patients undergoing bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 60 years old;
* Body mass index (BMI) ≥ 40 kg/m2;
* ASA classification I to III;
* Signing the informed consent form for this clinical study;

Exclusion Criteria:

* Respiratory infection within 4 weeks; severe respiratory system diseases; history of pulmonary and/or thoracic surgery; neuromuscular dysfunction;
* Serious cardiac, renal or haematopoietic diseases;
* Contraindications to PEEP；

Primary outcomes:
measure: Incidence of postoperative pulmonary atelectasis
timeFrame: After 30 minutes of extubation
Secondary outcomes:
measure: Postoperative pulmonary ultrasound score
timeFrame: After 30 minutes of extubation
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: yong t Sun, Ph.D
role: STUDY_CHAIR
References: