- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431242
Mechanical Power and Driving Pressure Exposure in Laparoscopic Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ilke dolgun
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
Study Locations
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Merkez Mahallesi
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Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
- Istinye University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled for elective laparoscopic abdominal surgery under general anesthesia
- Intraoperative mechanical ventilation with volume-controlled ventilation
- Provision of written informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Pulmonary Complications (PPCs)
Time Frame: Within 72 hours after surgery
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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).
|
Within 72 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Douville 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.
- El-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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- lap mp
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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