Postoperative Diaphragm Function in Pediatric Laparoscopic Abdominal Surgery Using Compliance and… (NCT07126067) | Clinical Trial Compass
CompletedNot Applicable
Postoperative Diaphragm Function in Pediatric Laparoscopic Abdominal Surgery Using Compliance and PEEP Guided by Lung Ultrasound
Turkey (Türkiye)45 participantsStarted 2024-12-25
Plain-language summary
Protective ventilation strategies and alveolar recruitment maneuvers (ARM) are employed in patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) to improve oxygenation, prevent alveolar collapse, and reduce ventilation-induced lung injury. Recruitment maneuvers aim to open and maintain alveoli. While positive effects on oxygenation have been observed in adults, limited data in children make the clinical efficacy of these strategies uncertain. Careful application and the development of individualized treatment protocols are recommended.
Who can participate
Age range
7 Years – 12 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:
* Participants meeting the following criteria will be included in the study:
* Aged 7 to 12 years
* ASA classification I, II, or III
* Undergoing elective laparoscopic abdominal surgery
Exclusion Criteria:
Participants with any of the following conditions will be excluded from the study:
* Age \<7 or \>12 years
* ASA classification \> III
* Uncontrolled bronchial asthma
* Presence of bullous lung disease
* Decompensated heart failure (NYHA Stage III-IV)
* History of lung surgery
* Increased intracranial or intraocular pressure
* Advanced hepatic or renal failure
* Parental refusal to participate in the study
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
Diaphragm thickness 1
Timeframe: Baseline measurement prior to anesthesia induction (within 30 minutes before surgery).
2
Diaphragm thickness 2
Timeframe: Immediately after extubation in the operating room (within 5 minutes of extubation).
3
Diaphragm thickness 3
Timeframe: 30 minutes after surgery completion (within the postoperative recovery period, up to 30 minutes).