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

April 8, 2025 updated by: Noor-Ul-Ain

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Bahawalpur, Punjab, Pakistan, 63100
        • Combined Military Hospital Bahawalpur
        • Contact:
        • Contact:
          • Dr Noor-Ul-Ain Registrar Anesthesia, MBBS
        • Contact:
          • Colonal Naseem Abbas, FCPS Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Driving pressure
Time Frame: 10 minutes after induction of general anesthesia, 10 minutes after pneumoperitonium creation and 10 minutes before extubation of patient
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
Time Frame: 10 minutes after induction of general anesthesia, 10 minutes after pneumoperitonium creation and 10 minutes before extubation of patient
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
Time Frame: 10 minutes after induction of general anesthesia and 10 minutes before extubation of patient

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noor-Ul-Ain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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