Comparison of 5 vs 8 cmH₂O PEEP on Respiratory Mechanics in Prone Lumbar Surgery (NCT07545733) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of 5 vs 8 cmH₂O PEEP on Respiratory Mechanics in Prone Lumbar Surgery
60 participantsStarted 2026-05-01
Plain-language summary
This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.
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:
* Patients aged between 18 and 65 years
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective lumbar spine surgery in the prone position
* Planned general anesthesia with total intravenous anesthesia (TIVA)
* Ability to provide informed consent
Exclusion Criteria:
* Body mass index (BMI) ≥ 30 kg/m²
* History of significant pulmonary disease (e.g., COPD, asthma)
* Severe cardiovascular disease
* Pregnancy
* Known difficult airway
* Requirement for intraoperative vasopressor infusion due to hemodynamic instability
* Conversion to different surgical position or change in surgical plan
* Incomplete data or protocol deviation
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
Driving Pressure (ΔP)
Timeframe: Intraoperative period (at predefined time points: T0, T2, T5)