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

NCT06929078 | Not Yet Recruiting

• 1 other identifier: HospitalBahawalpur
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mechanical ventilation; lung compliance; positive end-expiratory pressure; respiratory mechanics; oxygenation index; driving pressure

Outcome Measures

Primary Outcomes (3)

• Driving pressure

  Driving pressure is defined as airway plateau pressure minus positive end-expiratory pressure and reflects the degree of ventilator induced trauma. Airway plateau pressure and positive end-expiratory values will be taken from ventilator monitor.

  10 minutes after induction of general anesthesia, 10 minutes after pneumoperitonium creation and 10 minutes before extubation of patient

• Dynamic compliance of lungs

  Dynamic compliance is change in lung volume by the change in pressure in the presence of airflow and is calculated by dividing tidal volume of a breath with difference between peak pressure of airway and positive end-expiratory pressure. Tidal volume, peak airway pressure and positive end-expiratory pressure will be noted from ventilator machine monitor.

  10 minutes after induction of general anesthesia, 10 minutes after pneumoperitonium creation and 10 minutes before extubation of patient

• Oxygenation Index

  Oxygenation index is calculated by following formula: OI = Mean Airway Pressure × FiO2 × 100 ÷ PaO2 FiO2 (fractional inspiration of oxygen) and PaO2 (partial pressure of oxygen) will be recorded from arterial blood gas analysis.

  10 minutes after induction of general anesthesia and 10 minutes before extubation of patient

Study Arms (3)

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

PLACEBO COMPARATOR

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.

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

Individualized PEEP with recruitment maneuver guided by driving pressure measurement

EXPERIMENTAL

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.

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

Conventional ventilation

NO INTERVENTION

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

Interventions

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

Also known as: 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

5cm of water Positive End-expiratory Pressure will be applied after induction of general anesthesia; Individualized PEEP with recruitment maneuver guided by driving pressure measurement

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age Limit : 25 years to 65 years
• \. Patients undergoing laparoscopic suregeries
• \. ASA 1-3

You may not qualify if:

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

Sponsors & Collaborators

• Noor-Ul-Ain: lead

Study Sites (1)

Combined Military Hospital Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 32682559 BACKGROUND

• 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.

  PMID: 33843980 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Colonal Naseem Abbas

  Head of Department of Anesthesia Combined Military Hospital Bahawalpur

  PRINCIPAL INVESTIGATOR

• Dr Noor-Ul-Ain Registrar Anesthesia

  Department of Anesthesia Combined Military Hospital Bahawalpur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Noor-Ul-Ain, MBBS

CONTACT

+92332-6594515; noorulain0145@gmail.com

Dr Smavia Aslam, MBBS

CONTACT

+92312-7125450; smaviaaslam555@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Resident Anesthesiology Fellowship of College of Physicians and Surgeons Pakistan

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)