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Not yet recruiting NCT07431242

Mechanical Power and Driving Pressure Exposure in Laparoscopic Surgery

Observational Postoperative Pulmonary Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoperative Ventilatory Load Exposure (Mechanical Power and Driving Pressure).
Who it may be relevant to
Registry conditions: Postoperative Pulmonary Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Time-Dependent Exposure to Intraoperative Mechanical Power and Driving Pressure and Postoperative Pulmonary Outcomes in Laparoscopic Surgery

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Postoperative Pulmonary Complications (PPCs) [Time frame: Within 72 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

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. PMID 26174419
  • 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 PMID 36687665
  • 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

Identifiers

NCT: NCT07431242 · lap mp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗