Not Yet RecruitingNot Applicable

Optimal PEEP for Postoperative Oxygenation and Lung Aeration (ULTRASVENT-2)

Russia360 participantsStarted 2026-07-01

Plain-language summary

The purpose of this multicenter, randomized controlled trial (ULTRASVENT-2) is to evaluate the effect of different positive end-expiratory pressure (PEEP) levels on postoperative oxygenation and lung aeration in adult patients undergoing elective non-cardiac and non-thoracic surgery under general anesthesia. Moving away from traditional binary outcomes, this study utilizes a continuous functional metric, the non-invasive oxygenation index SpO2/FiO2 (S/F ratio), as the primary endpoint to precisely capture the degree of respiratory function preservation. Patients will be stratified into four distinct surgical cohorts based on the type and aggressiveness of the procedure: non-abdominal surgery, major open abdominal surgery, major laparoscopic abdominal surgery, and low-trauma laparoscopic surgery. This adaptive design aims to investigate how protective PEEP strategies interact with varying degrees of surgical trauma and intraoperative pneumoperitoneum, allowing the optimization of mechanical ventilation parameters for routine clinical practice.

Who can participate

Age range

18 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: * Age greater than or equal to 18 years. * Planned elective non-cardiac and non-thoracic surgical intervention requiring general anesthesia with mechanical ventilation. * Airway protection utilizing an endotracheal tube. * Assignment to one of the four specific surgical strata: non-abdominal, major open abdominal, major laparoscopic abdominal, or low-trauma laparoscopic surgery. * Baseline lung ultrasound showing no pathological findings, corresponding to a total preoperative LUS score of 0. * Technical feasibility of performing a postoperative lung ultrasound within the first 2 hours after the completion of surgery. * Signed written informed consent to participate in the clinical trial. Exclusion Criteria: * Planned cardiac or thoracic surgery (e.g., coronary artery bypass grafting, valve replacement, heart transplantation, lung resection, esophageal surgery). * Pneumothorax diagnosed before or during the surgical procedure. * Inability to adequately visualize the target dorsal-basal lung zones by ultrasound due to physical limitations (e.g., morbid obesity, massive surgical dressings, anatomical anomalies, or dermatological lesions in the scanning area). * Presence of hydrothorax detected on the baseline preoperative ultrasound. * Confirmed perioperative aspiration of gastric contents or other foreign material. * Any pathological changes identified during the baseline ultrasound of the dorsal-basal lung regions (a total preoperative LUS score greater …

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

Non-invasive oxygenation index (SpO2/FiO2 ratio)

Timeframe: Assessed at 3 time points: preoperatively (baseline); exactly 2 hours post-extubation; and 24 hours post-operation.

Trial details

NCT IDNCT07613177

SponsorMoscow Multidisciplinary Clinical Center "Kommunarka"

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Ivan Shcheparev, MD, PhD

+7 901 908 90 88 is22@list.ru

View on ClinicalTrials.gov More Postoperative Complications trials