Mechanical Power and Driving Pressure Exposure in Laparoscopic Surgery

NCT07431242 | Not Yet Recruiting

• 1 other identifier: lap mp
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 72 hours after surgery

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age ≥ 18 years
• Scheduled for elective laparoscopic abdominal surgery under general anesthesia
• Intraoperative mechanical ventilation with volume-controlled ventilation
• Provision of written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 26174419 RESULT

• 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.

  PMID: 36687665 RESULT

• 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.

  PMID: 38413871 RESULT

Central Study Contacts

İLKE DOLĞUN

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

TU (1)