NCT06115668

Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamics, and Early Postoperative Atelectasis in Laparoscopic Bariatric Surgery

Effects of Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamic Variables, and Incidence of Early Postoperative Atelectasis in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing laparoscopic bariatric surgery.

Detailed description

Obesity is a major health problem, and the incidence is increasing worldwide. So far, the only treatment for morbid obesity with good long-term results is bariatric surgery. Obese patients have unique respiratory physiology and ventilatory mechanics characteristics. Their lung function is impaired due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. In addition, they frequently present with respiratory comorbidities, which increases the risk of developing postoperative pulmonary complications (PPCs) such as atelectasis especially after procedures under general anesthesia. Atelectasis has been hypothesized as a main cause of postoperative hypoxemia. To reduce the incidence of atelectasis, positive end-expiratory pressure (PEEP) and recruitment maneuvers are used as a protective lung strategy to improve gas exchange and lung mechanics through reopening collapsed alveoli and maintaining the aeration of lungs. Application of PEEP may also eliminate auto-PEEP without increasing plateau pressure.

Conditions

• Positive End-expiratory Pressure
• Hemodynamic Variable
• Postoperative Atelectasis
• Laparoscopic Bariatric Surgery

Interventions

Type	Name	Description
OTHER	Positive end-expiratory pressure 5 (PEEP 5)	Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery
OTHER	Individualized positive end-expiratory pressure (PEEPIND)	Patients will receive the individualized positive end-expiratory pressure. Titration process will be started after establishment of pneumoperitoneum: setting the initial PEEP to 5 cmH2O, then increasing positive end-expiratory pressure (PEEP)according to the gradient of 2 cmH2O every 3 min, calculating static compliance (Cstat) according to the formula: \[Cstat = VT/Pplat - PEEP\] (Pplat = plateau pressure), then gradually increasing positive end-expiratory pressure , until the calculated Cstat shows a downward trend, set its previous PEEP (corresponding to PEEP for high Cstat) as the optimal PEEPIND for this patient. The highest PEEP is limited to 20 cmH2O

Timeline

• Start date: 2023-11-05
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-11-03
• Last updated: 2023-11-07

Locations

1 site across 1 country: Egypt