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

NCT06115668 | Unknown

• 1 other identifier: 36131/11/22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean arterial pressure(MAP)

  One hour after extubation

• Heart rate(HR)

  One hour after extubation

• Volume of total fluid infusion

  Till the end of surgery

• Dosage of vasopressors

  Till the end of surgery

• Lung ultrasound scores

  12 hours postoperatively

Study Arms (2)

Positive end-expiratory pressure 5 (PEEP 5)

ACTIVE COMPARATOR

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

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

Individualized positive end-expiratory pressure (PEEPIND)

EXPERIMENTAL

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

Other: Individualized positive end-expiratory pressure (PEEPIND)

Interventions

Positive end-expiratory pressure 5 (PEEP 5) OTHER

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

Positive end-expiratory pressure 5 (PEEP 5)

Individualized positive end-expiratory pressure (PEEPIND) 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

Individualized positive end-expiratory pressure (PEEPIND)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Heba Z Khattab, Master

CONTACT

00201004774825; hebazakaria194@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: November 5, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)