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

Role of Individualized Positive End-expiratory Pressure Versus Fixed Positive End-expiratory Pressure in Mechanical Ventilation During Laparoscopic Surgeries

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Surgery; Pneumoperitoneum; Positive End Expiratory Pressure (PEEP)
• Intervention / Treatment: Other: Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Noor-Ul-Ain, MBBS; Phone Number: +92332-6594515; Email: noorulain0145@gmail.com
• Study Contact Backup: Name: Dr Smavia Aslam, MBBS; Phone Number: +92312-7125450; Email: smaviaaslam555@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Bahawalpur, Punjab, Pakistan, 63100
      • Combined Military Hospital Bahawalpur
      • Contact: Dr. Noor-Ul-Ain Registrar Anesthesia, MBBS; Phone Number: +92332-6594515; Email: noorulain0145@gmail.com
      • Contact: Dr Noor-Ul-Ain Registrar Anesthesia, MBBS
      • Contact: Colonal Naseem Abbas, FCPS Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Other: 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.; Other 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
Experimental: 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.	Other: 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.; Other 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
No Intervention: Conventional ventilation; Conventional ventilation method without additional positive end-expiratory pressure will be applied to participants during mechanical ventilation undergoing laparoscopic surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Noor-Ul-Ain
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; respiratory mechanics; positive end-expiratory pressure; driving pressure; lung compliance; oxygenation index
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: HospitalBahawalpur

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No