Laparoscopic SurgeryNCT06929078
Role of Individualized PEEP Vs Fixed PEEP in Mechanical Ventilation During Laparoscopic Surgeries
A study testing Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries in people with Laparoscopic Surgery and Pneumoperitoneum, run by Noor-Ul-Ain at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery, Pneumoperitoneum, Positive End Expiratory Pressure (PEEP)
- What is being tested?
- Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- May 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age Limit : 25 years to 65 years
- 2. Patients undergoing laparoscopic suregeries
- 3. ASA 1-3
Who cannot join
- 1. Hemodynamic instability 2. Bronchospam 3. Patients having COPD 4. History of pulmonary bulla 5. Patients having history of pneumothora
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Combined Military Hospital Bahawalpur
Bahawalpur, Punjab Province, 63100
Dr. Noor-Ul-Ain Registrar Anesthesia, MBBS, +92332-6594515, noorulain0145@gmail.com
Dr Noor-Ul-Ain Registrar Anesthesia, MBBS
About this study
Official title: 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.
Read the 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.
- Being tested
- Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries
- Keywords
- mechanical ventilation, lung compliance, positive end-expiratory pressure, respiratory mechanics, oxygenation index, driving pressure
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic SurgeriesOther
Also called Application of possitive end expiratory pressure during laparoscopic surgeries, Individual PEEP with recruitment maneuver, Fixed PEEP, Protective lung ventilation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10 minutes after induction of general anesthesia and 10 minutes before extubation of patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noor-Ul-Ain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noor-Ul-Ain, Combined Military Hospital Bahawalpur
- Investigators
- Colonal Naseem Abbas, Principal investigator, Head of Department of Anesthesia Combined Military Hospital BahawalpurDr Noor-Ul-Ain Registrar Anesthesia, Principal investigator, Department of Anesthesia Combined Military Hospital Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929078
- Sponsor's protocol ID
- HospitalBahawalpur
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32682559Simon 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.
PubMed 33843980
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Individualized Positive End-expiratory Pressure Versus Fixed Positive End-expiratory Pressure in Mechanical Ventilation During Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT06929078
- Acronym / sponsor ID
- HospitalBahawalpur
- Keywords
- mechanical ventilation, lung compliance, positive end-expiratory pressure, respiratory mechanics, oxygenation index, driving pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Noor-Ul-AinUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 5cm of water Positive End-expiratory Pressure will be applied after induction of general anesthesia | Placebo comparator | Other: Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic SurgeriesA 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. |
| Individualized PEEP with recruitment maneuver guided by driving pressure measurement | Experimental | Other: Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic SurgeriesRecruitment 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. |
| Conventional ventilation | No intervention | –Conventional ventilation method without additional positive end-expiratory pressure will be applied to participants during mechanical ventilation undergoing laparoscopic surgeries. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age Limit : 25 years to 65 years
- 2. Patients undergoing laparoscopic suregeries
- 3. ASA 1-3
Key exclusion criteria (1 listed)
- 1. Hemodynamic instability 2. Bronchospam 3. Patients having COPD 4. History of pulmonary bulla 5. Patients having history of pneumothora
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic SurgeriesAlso: Application of possitive end expiratory pressure during laparoscopic surgeries, Individual PEEP with recruitment maneuver, Fixed PEEP, Protective lung ventilationProtective 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 | 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 |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 32682559Fernandez-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.
- Background: PubMed 33843980Simon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colonal Naseem Abbas principal investigator
Head of Department of Anesthesia Combined Military Hospital Bahawalpur
Dr Noor-Ul-Ain Registrar Anesthesia principal investigator
Department of Anesthesia Combined Military Hospital Bahawalpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective lung ventilation methods with different positive end-expiratory pressure during Laparoscopic Surgeries in people with Laparoscopic Surgery and Pneumoperitoneum, run by Noor-Ul-Ain at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Noor-Ul-Ain, MBBS (+92332-6594515, noorulain0145@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving pressure (time frame: 10 minutes after induction of general anesthesia, 10 minutes after pneumoperitonium creation and 10 minutes before extubation of patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06929078, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.