Skip to main content
Clinical Trials/NCT06115668
NCT06115668
Recruiting
Not Applicable

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

Tanta University1 site in 1 country80 target enrollmentNovember 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Positive End-expiratory Pressure
Sponsor
Tanta University
Enrollment
80
Locations
1
Primary Endpoint
Intraoperative oxygenation
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2023
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Zakaria Mohamed Khattab

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

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.

Outcomes

Primary Outcomes

Intraoperative oxygenation

Time Frame: One hour after extubation

Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). PaO2/FiO2: will be measured at before induction of anesthesia, immediately after intubation, after PEEP titration, one hour after pneumoperitoneum, before extubation, one hour after extubation

Secondary Outcomes

  • Mean arterial pressure(MAP)(One hour after extubation)
  • Dosage of vasopressors(Till the end of surgery)
  • Heart rate(HR)(One hour after extubation)
  • Lung ultrasound scores(12 hours postoperatively)
  • Early postoperative pulmonary complication(First 24 hours postoperatively)
  • Volume of total fluid infusion(Till the end of surgery)
  • Length of hospital stay(28 days postoperatively)

Study Sites (1)

Loading locations...

Similar Trials