Postoperative Pulmonary ComplicationsNCT07431242
Mechanical Power and Driving Pressure Exposure in Laparoscopic Surgery
An observational study of Postoperative Pulmonary Complications, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pulmonary complications (PPCs) remain an important cause of morbidity after abdominal surgery. Intraoperative mechanical ventilation may contribute to lung injury through the mechanical load applied to the respiratory system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications
- What is being tested?
- Intraoperative Ventilatory Load Exposure (Mechanical Power and Driving Pressure)
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 15 Jul 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center. All participants will receive routine intraoperative volume-controlled mechanical ventilation as part of standard clinical practice. The study will include patients meeting predefined eligibility criteria, and no protocol-based modifications to anesthetic or ventilatory management will be performed.
Who may be able to join
- Age ≥ 18 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- Intraoperative mechanical ventilation with volume-controlled ventilation
- Provision of written informed consent
Who cannot join
- Emergency surgery
- Conversion to open surgery
- Preoperative invasive or noninvasive mechanical ventilation
- Intraoperative major complications requiring substantial deviation from routine ventilation management
- Incomplete intraoperative or postoperative data
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Time-Dependent Exposure to Intraoperative Mechanical Power and Driving Pressure and Postoperative Pulmonary Outcomes in Laparoscopic Surgery
Postoperative pulmonary complications (PPCs) remain an important cause of morbidity after abdominal surgery. Intraoperative mechanical ventilation may contribute to lung injury through the mechanical load applied to the respiratory system. Mechanical power (MP) and driving pressure (DP) have emerged as integrative parameters reflecting the total ventilatory burden delivered to the lungs.
This prospective observational study aims to evaluate the association between time-dependent exposure to intraoperative mechanical power and driving pressure and postoperative pulmonary outcomes in patients undergoing elective laparoscopic abdominal surgery. Ventilatory parameters will be recorded at predefined intervals during routine clinical care, and MP and DP will be calculated without altering clinical management. The primary objective is to assess whether longer exposure to elevated ventilatory load is associated with the development of postoperative pulmonary complications.
- Conditions
- Postoperative Pulmonary Complications
- Being tested
- Intraoperative Ventilatory Load Exposure (Mechanical Power and Driving Pressure)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Ventilatory Load Exposure (Mechanical Power and Driving Pressure)Other
Intraoperative ventilatory load exposure is defined as the time-dependent exposure to calculated mechanical power (MP) and driving pressure (DP) values recorded during routine volume-controlled mechanical ventilation. No protocol-driven modification of ventilatory settings will be performed. Mechanical power and driving pressure will be calculated from standard ventilator parameters obtained during routine clinical care, and exposure duration above predefined threshold values will be analyzed in relation to postoperative pulmonary outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pulmonary Complications (PPCs)
Occurrence of postoperative pulmonary complications within the early postoperative period, including prolonged oxygen requirement, hypoxemia (SpO₂ < 92% on room air), need for non-invasive ventilation, or reintubation. PPC will be recorded as a composite binary outcome (present/absent).
Measured: Within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431242
- Sponsor's protocol ID
- lap mp
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.
PubMed 26174419Douville NJ, McMurry TL, Ma JZ, Naik BI, Mathis MR, Colquhoun D, Kheterpal S, Pace NL, Hedrick TL, Blank RS; Multicenter Perioperative Outcomes Group (MPOG) Perioperative Clinical Research Committee. Airway driving pressure is associated with postoperative pulmonary complications after major abdominal surgery: a multicentre retrospective observational cohort study. BJA Open. 2022 Dec;4:100099. doi: 10.1016/j.bjao.2022.100099. Epub 2022 Oct 18.
PubMed 36687665El-Khatib M, Zeeni C, Shebbo FM, Karam C, Safi B, Toukhtarian A, Nafeh NA, Mkhayel S, Shadid CA, Chalhoub S, Beresian J. Intraoperative mechanical power and postoperative pulmonary complications in low-risk surgical patients: a prospective observational cohort study. BMC Anesthesiol. 2024 Feb 27;24(1):82. doi: 10.1186/s12871-024-02449-1.
PubMed 38413871
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Dependent Exposure to Intraoperative Mechanical Power and Driving Pressure and Postoperative Pulmonary Outcomes in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07431242
- Acronym / sponsor ID
- lap mp
- Conditions
- Postoperative Pulmonary Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
Postoperative pulmonary complications (PPCs) remain an important cause of morbidity after abdominal surgery. Intraoperative mechanical ventilation may contribute to lung injury through the mechanical load applied to the respiratory system. Mechanical power (MP) and driving pressure (DP) have emerged as integrative parameters reflecting the total ventilatory burden delivered to the lungs.
This prospective observational study aims to evaluate the association between time-dependent exposure to intraoperative mechanical power and driving pressure and postoperative pulmonary outcomes in patients undergoing elective laparoscopic abdominal surgery. Ventilatory parameters will be recorded at predefined intervals during routine clinical care, and MP and DP will be calculated without altering clinical management. The primary objective is to assess whether longer exposure to elevated ventilatory load is associated with the development of postoperative pulmonary complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing elective laparoscopic abdominal surgery under general anesthesia at a tertiary care center. All participants will receive routine intraoperative volume-controlled mechanical ventilation as part of standard clinical practice. The study will include patients meeting predefined eligibility criteria, and no protocol-based modifications to anesthetic or ventilatory management will be performed.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- Intraoperative mechanical ventilation with volume-controlled ventilation
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Emergency surgery
- Conversion to open surgery
- Preoperative invasive or noninvasive mechanical ventilation
- Intraoperative major complications requiring substantial deviation from routine ventilation management
- Incomplete intraoperative or postoperative data
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 |
|---|---|---|
| Intraoperative Ventilatory Load Exposure (Mechanical Power and Driving Pressure)Intraoperative ventilatory load exposure is defined as the time-dependent exposure to calculated mechanical power (MP) and driving pressure (DP) values recorded during routine volume-controlled mechanical ventilation. No protocol-driven modification of ventilatory settings will be performed. Mechanical power and driving pressure will be calculated from standard ventilator parameters obtained during routine clinical care, and exposure duration above predefined threshold values will be analyzed in relation to postoperative pulmonary outcomes. | Other | – |
Primary outcome
Postoperative Pulmonary Complications (PPCs)
Time frame: Within 72 hours after surgery
Occurrence of postoperative pulmonary complications within the early postoperative period, including prolonged oxygen requirement, hypoxemia (SpO₂ < 92% on room air), need for non-invasive ventilation, or reintubation. PPC will be recorded as a composite binary outcome (present/absent).
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 24 Feb 2026.
- Results publication: PubMed 26174419Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.
- Results publication: PubMed 36687665Douville NJ, McMurry TL, Ma JZ, Naik BI, Mathis MR, Colquhoun D, Kheterpal S, Pace NL, Hedrick TL, Blank RS; Multicenter Perioperative Outcomes Group (MPOG) Perioperative Clinical Research Committee. Airway driving pressure is associated with postoperative pulmonary complications after major abdominal surgery: a multicentre retrospective observational cohort study. BJA Open. 2022 Dec;4:100099. doi: 10.1016/j.bjao.2022.100099. Epub 2022 Oct 18.
- Results publication: PubMed 38413871El-Khatib M, Zeeni C, Shebbo FM, Karam C, Safi B, Toukhtarian A, Nafeh NA, Mkhayel S, Shadid CA, Chalhoub S, Beresian J. Intraoperative mechanical power and postoperative pulmonary complications in low-risk surgical patients: a prospective observational cohort study. BMC Anesthesiol. 2024 Feb 27;24(1):82. doi: 10.1186/s12871-024-02449-1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Complications, run by Istinye University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 24 Feb 2026. 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 Turkey (Türkiye). 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. 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 İLKE DOLĞUN (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pulmonary Complications (PPCs) (time frame: Within 72 hours after surgery). 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 NCT07431242, which also lists 3 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 24 Feb 2026.