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

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Bariatric Surgery; Postoperative Atelectasis; Positive End-expiratory Pressure; Hemodynamic Variable
• Intervention / Treatment: Other: Positive end-expiratory pressure 5 (PEEP 5); Other: Individualized positive end-expiratory pressure (PEEPIND)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba Z Khattab, Master; Phone Number: 00201004774825; Email: hebazakaria194@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Shaimaa F Abdelkader, MD
      • Contact: Heba Z Khattab; Phone Number: 00201004774825; Email: hebazakaria194@gmail.com
      • Sub-Investigator: Ahmed M El-Sheikh, MD
      • Sub-Investigator: Mohamed A Barrima, MD
      • Sub-Investigator: Laila A Al Ahwal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive end-expiratory pressure 5 (PEEP 5); Patients will receive fixed positive end-expiratory pressure(= 5 cmH2O) as a control group	Other: Positive end-expiratory pressure 5 (PEEP 5); Fixed positive end-expiratory pressure of 5 cmH2O will be maintained throughout the duration of surgery
Experimental: Individualized positive end-expiratory pressure (PEEPIND); Patients who will receive the individualized positive end-expiratory pressure.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative oxygenation	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	One hour after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure(MAP)	Mean arterial pressure will be measured before induction of anesthesia, immediately after intubation, after positive End-Expiratory Pressure titration, one hour after pneumoperitoneum, before extubation, and one hour after extubation.	One hour after extubation
Heart rate(HR)	Heart rate will be measured before induction of anesthesia, immediately after intubation, after positive End-Expiratory Pressure titration, one hour after pneumoperitoneum, before extubation, and one hour after extubation.	One hour after extubation
Volume of total fluid infusion	The total volume of the administered fluids will be recorded.	Till the end of surgery
Dosage of vasopressors	The total volume of the administered vasopressors will be recorded.	Till the end of surgery
Lung ultrasound scores	Lung ultrasound scans will be performed 3 times for each patient, before induction of anesthesia, one hour after extubation and 12 hours postoperatively. Patients will be scanned in the supine position as follows: Each hemithorax will be divided into 6 regions using 3 longitudinal lines (parasternal, anterior, and posterior axillary) and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12-lung regions will be scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region will be assessed using a 2-dimensional view with the probe placed parallel to the ribs. The degree of B-lines will be divided into 4 grades according to lung ultrasound score for consolidation and aeration and scored between 0 and 3: (0) fewer than 3 isolated B-lines.; multiple well-defined B-lines.; multiple coalescent B-lines.; white lung.	12 hours postoperatively
Early postoperative pulmonary complication	Any early postoperative pulmonary complication in the first postoperative 24 hours will be recorded.	First 24 hours postoperatively
Length of hospital stay	Time from admission till hospital discharge	28 days postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 36131/11/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No