Mechanical Power and Driving Pressure Exposure in Laparoscopic Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstinye University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Scheduled for elective laparoscopic abdominal surgery under general anesthesia
Intraoperative mechanical ventilation with volume-controlled ventilation
Provision of written informed consent
Disqualifiers
Emergency surgery
Conversion to open surgery
Preoperative invasive or noninvasive mechanical ventilation
Intraoperative major complications requiring substantial deviation from routine ventilation management
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intraoperative Ventilatory Load Exposure (Mechanical Power and Driving Pressure)
Other interventionIntraoperative 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.
Treatment groups
No treatment groups listed
Trial outcomes
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).
Time frame
Within 72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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