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

NCT ID: NCT06115668

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive end-expiratory pressure 5 (PEEP 5)

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

Group Type: ACTIVE_COMPARATOR

Positive end-expiratory pressure 5 (PEEP 5)

Intervention Type: OTHER

Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery

Individualized positive end-expiratory pressure (PEEPIND)

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

Group Type: EXPERIMENTAL

Individualized positive end-expiratory pressure (PEEPIND)

Intervention Type: OTHER

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

Interventions

Positive end-expiratory pressure 5 (PEEP 5)

Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Heba Zakaria Mohamed Khattab

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Heba Z Khattab, Master

Role: CONTACT

hebazakaria194@gmail.com

00201004774825

Facility Contacts

Heba Z Khattab

Role: primary

hebazakaria194@gmail.com

00201004774825

Other Identifiers

36131/11/22

Identifier Type: -

Identifier Source: org_study_id