Comparison of Standard Versus Dynamic Compliance-Guided Individualized PEEP in Obese Patients Und… (NCT07388719) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Standard Versus Dynamic Compliance-Guided Individualized PEEP in Obese Patients Undergoing Spinal Surgery
Turkey (Türkiye)80 participantsStarted 2025-02-02
Plain-language summary
This study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Obesity and prone positioning during spinal surgery are associated with reduced lung compliance, atelectasis, and an increased risk of postoperative pulmonary complications.
Participants will be allocated to receive either a fixed standard PEEP or an individualized PEEP level determined according to intraoperative dynamic lung compliance. Intraoperative oxygenation, respiratory mechanics, arterial blood gas parameters, and hemodynamic variables will be assessed at predefined time points. Postoperative pulmonary complications within the first 24 hours after surgery will also be evaluated.
The study seeks to determine whether individualized PEEP titration based on dynamic compliance offers physiological or clinical advantages compared with a standard PEEP strategy in this patient population.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients aged 18-65 years
* Body mass index (BMI) ≥30 kg/m²
* Scheduled for elective spinal surgery under general anesthesia
* Requirement for intraoperative mechanical ventilation
* American Society of Anesthesiologists (ASA) physical status II-III
* Provision of written informed consent
Exclusion Criteria:
* Pre-existing severe pulmonary disease (e.g., COPD GOLD stage III-IV, restrictive lung disease)
* Severe cardiac disease (e.g., heart failure with reduced ejection fraction, significant valvular disease)
* History of thoracic surgery affecting lung mechanics
* Pregnancy
* Emergency surgery
* Intraoperative need for deviation from the planned ventilation protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
Timeframe: From induction of anesthesia until the end of surgery