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

Tanta University

Status: Enrolling

Conditions: Hemodynamic Variable; Laparoscopic Bariatric Surgery; Positive End-expiratory Pressure; Postoperative Atelectasis

Treatments: Other: Positive end-expiratory pressure 5 (PEEP 5); Other: Individualized positive end-expiratory pressure (PEEPIND)

Study type: Interventional

Funder types: Other

Identifiers

NCT06115668

36131/11/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 21 to 60 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status class I-III
• Patients who are scheduled for elective laparoscopic bariatric surgery under general anesthesia.

Exclusion criteria

• Patients who are unwilling to participate in the study
• Actively smokers.
• Patients who had a history of Chronic obstructive pulmonary disease or bronchial asthma.
• Patients who are receiving renal replacement therapy prior to surgery.
• Patients who had a history of heart failure.
• Pregnant.
• Patients who have allergies to any drug used in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Positive end-expiratory pressure 5 (PEEP 5)

Active Comparator group

Description:

Patients will receive fixed positive end-expiratory pressure(= 5 cmH2O) as a control group

Treatment:

Other: Positive end-expiratory pressure 5 (PEEP 5)

Individualized positive end-expiratory pressure (PEEPIND)

Experimental group

Description:

Patients who will receive the individualized positive end-expiratory pressure.

Treatment:

Other: Individualized positive end-expiratory pressure (PEEPIND)