Role of Individualized PEEP Vs Fixed PEEP in Mechanical Ventilation During Laparoscopic Surgeries

NCT ID: NCT06929078

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-11-30

Brief Summary

To compare the effects of Individualized positive end-expiratory pressure with recruitment maneuver on respiratory parameters and oxygenation in mechanical ventilation during laparoscopic surgeries with the fixed positive end-expiratory pressure and conventional mechanical ventilation without positive end-expiratory pressure.

Detailed Description

Thus study will compare the effects different methods of positive end-expiratory pressure administration in mechanical ventilation on respiratory parameters and oxygenation of the patients undergoing laparoscopic surgeries. There will be three groups of patients which will be as follows: Individualized positive end-expiratory pressure with recruitment maneuver group, fixed positive end-expiratory pressure group and conventional mechanical ventilation. Respiratory parameters; dynamic compliance, driving pressure and ratio of partial pressure of oxygen to fractional inspiration of oxygen will be measured. Mechanical ventilation respiratory parameters i .e. peak pressure, plateu pressure , dynamic compliance and driving pressure will be measured from ventilator machine. P/F ratio( Ratio of partial pressure of oxygen to inspiratory fraction of oxygen) will be measured by taking blood samples for arterial blood gas analysis.

Conditions

Laparoscopic Surgery; Pneumoperitoneum; Positive End Expiratory Pressure (PEEP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

5cm of water Positive End-expiratory Pressure will be applied after induction of general anesthesia

A fixed positive end-expiratory pressure of 5cm of water will administered to the participants after induction of general anesthesia during mechanical ventilation undergoing laparoscopic surgeries.

Group Type: PLACEBO_COMPARATOR

Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries

Intervention Type: OTHER

Protective lung ventilation methods with positive end-expiratory pressure help in prevention of atelectasis and improvement of intraoperative ventilator parameters e.g low driving pressure and improved dynamic compliance resulting in better oxygenation of lungs ere will be three groups in this study. Individualized positive end-expiratory pressure with recruitment maneuver and fixed positive end-expiratory pressure will be interventional groups. They will be compared with conventional ventilation group in which no additional positive end-expiratory pressure will be applied. The effects on respiratory parameters and oxygenation of patients will be compared for each group. This study will determine which method of positive end-expiratory pressure is superior and how it differs from conventional ventilation for prevention of atelectasis induced by pneumoperitonium and improvement of respiratory mechanical parameters and oxygenation in Mechanical ventilation during laparoscopic surgeries.

Individualized PEEP with recruitment maneuver guided by driving pressure measurement

Recruitment maneuver will be applied after induction of general anesthesia and indiviualized positive end-expiratory pressure will be applied guided by driving pressue during mechanical ventilation during laparoscopic surgeries.

Group Type: EXPERIMENTAL

Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries

Intervention Type: OTHER

Protective lung ventilation methods with positive end-expiratory pressure help in prevention of atelectasis and improvement of intraoperative ventilator parameters e.g low driving pressure and improved dynamic compliance resulting in better oxygenation of lungs ere will be three groups in this study. Individualized positive end-expiratory pressure with recruitment maneuver and fixed positive end-expiratory pressure will be interventional groups. They will be compared with conventional ventilation group in which no additional positive end-expiratory pressure will be applied. The effects on respiratory parameters and oxygenation of patients will be compared for each group. This study will determine which method of positive end-expiratory pressure is superior and how it differs from conventional ventilation for prevention of atelectasis induced by pneumoperitonium and improvement of respiratory mechanical parameters and oxygenation in Mechanical ventilation during laparoscopic surgeries.

Conventional ventilation

Conventional ventilation method without additional positive end-expiratory pressure will be applied to participants during mechanical ventilation undergoing laparoscopic surgeries.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries

Protective lung ventilation methods with positive end-expiratory pressure help in prevention of atelectasis and improvement of intraoperative ventilator parameters e.g low driving pressure and improved dynamic compliance resulting in better oxygenation of lungs ere will be three groups in this study. Individualized positive end-expiratory pressure with recruitment maneuver and fixed positive end-expiratory pressure will be interventional groups. They will be compared with conventional ventilation group in which no additional positive end-expiratory pressure will be applied. The effects on respiratory parameters and oxygenation of patients will be compared for each group. This study will determine which method of positive end-expiratory pressure is superior and how it differs from conventional ventilation for prevention of atelectasis induced by pneumoperitonium and improvement of respiratory mechanical parameters and oxygenation in Mechanical ventilation during laparoscopic surgeries.

Intervention Type: OTHER

Other Intervention Names

Application of possitive end expiratory pressure during laparoscopic surgeries; Individual PEEP with recruitment maneuver; Fixed PEEP; Protective lung ventilation; Different positive end-expiratory pressure strategies

Eligibility Criteria

Inclusion Criteria

• 1. Age Limit : 25 years to 65 years

2. Patients undergoing laparoscopic suregeries

3. ASA 1-3

Exclusion Criteria

• 1. Hemodynamic instability 2. Bronchospam 3. Patients having COPD 4. History of pulmonary bulla 5. Patients having history of pneumothora

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Noor-Ul-Ain

OTHER

Sponsor Role: lead

Responsible Party

Noor-Ul-Ain

Post Graduate Resident Anesthesiology Fellowship of College of Physicians and Surgeons Pakistan

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Colonal Naseem Abbas

Role: PRINCIPAL_INVESTIGATOR

Head of Department of Anesthesia Combined Military Hospital Bahawalpur

Dr Noor-Ul-Ain Registrar Anesthesia

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia Combined Military Hospital Bahawalpur

Locations

Combined Military Hospital Bahawalpur

Bahawalpur, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Dr. Noor-Ul-Ain, MBBS

Role: CONTACT

noorulain0145@gmail.com

+92332-6594515

Dr Smavia Aslam, MBBS

Role: CONTACT

smaviaaslam555@gmail.com

+92312-7125450

Facility Contacts

Dr. Noor-Ul-Ain Registrar Anesthesia, MBBS

Role: primary

noorulain0145@gmail.com

+92332-6594515

References

Fernandez-Bustamante A, Sprung J, Parker RA, Bartels K, Weingarten TN, Kosour C, Thompson BT, Vidal Melo MF. Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):383-392. doi: 10.1016/j.bja.2020.06.030. Epub 2020 Jul 16.

Reference Type: BACKGROUND

PMID: 32682559 (View on PubMed)

Simon P, Girrbach F, Petroff D, Schliewe N, Hempel G, Lange M, Bluth T, Gama de Abreu M, Beda A, Schultz MJ, Pelosi P, Reske AW, Wrigge H; PROBESE Investigators of the Protective Ventilation Network* and the Clinical Trial Network of the European Society of Anesthesiology. Individualized versus Fixed Positive End-expiratory Pressure for Intraoperative Mechanical Ventilation in Obese Patients: A Secondary Analysis. Anesthesiology. 2021 Jun 1;134(6):887-900. doi: 10.1097/ALN.0000000000003762.

Reference Type: BACKGROUND

PMID: 33843980 (View on PubMed)

Other Identifiers

HospitalBahawalpur

Identifier Type: -

Identifier Source: org_study_id