Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in … (NCT06471491) | Clinical Trial Compass
CompletedNot Applicable
Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial
China40 participantsStarted 2024-09-11
Plain-language summary
At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Therefore, the investigators hypothesized that intraoperative use of LPV strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.
Who can participate
Age range
3 Years – 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 3-18 years old;
* According to the People's Republic of China health industry standard "Overweight and Obesity Screening threshold for school-age children and adolescents WS\_T586-2018" defined as obesity;
* American Society of Anesthesiologists (ASA) grades I - II;
* Children with healthy lungs and hearts;
* Patients with general anesthesia under tracheal intubation;
* Clear mind and able to cooperate with the anesthesiologist to receive treatment;
* Patients who plan to have elective surgery under general anesthesia and the estimated operation duration is ≥2 hours.
Exclusion Criteria:
* PEEP contraindications: (a) bronchopleural fistula; (b) hypovolemic shock; (c) right ventricular failure;
* American Society of Anesthesiologists (ASA) grade greater than II;
* Pulmonary dysfunction, congenital heart disease children;
* Refusal to participate in the study and/or use personal data, preoperative intubation or ventilation of children;
* Children with upper respiratory tract infection within 2 weeks.
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
Incidence of atelectasis in both groups at the end of surgery