Not Yet RecruitingNot Applicable

Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

Turkey (Türkiye)62 participantsStarted 2026-01-15

Plain-language summary

Laparoscopic cholecystectomy and the associated pneumoperitoneum can impair diaphragmatic mechanics and reduce postoperative oxygenation. This prospective observational study aims to evaluate perioperative changes in diaphragmatic excursion measured by ultrasonography and to investigate their association with early postoperative oxygenation parameters and hypoxemia. By correlating diaphragmatic excursion changes with SpO₂/FiO₂ and the ROX index, the study seeks to clarify the physiological contribution of diaphragmatic dysfunction to postoperative hypoxemia in patients undergoing laparoscopic cholecystectomy.

Who can participate

Age range

18 Years – 75 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: * Adults aged 18-75 years * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * Able to undergo diaphragm ultrasonography (no preoperative barrier to assessment) * Able to cooperate with preoperative and early postoperative diaphragm measurements * Postoperative oxygenation data available (SpO₂, FiO₂, and SpO₂/FiO₂ can be recorded) * Provided written informed consent Exclusion Criteria: * Morbid obesity (BMI ≥ 40 kg/m²) * Known diaphragmatic paralysis, phrenic nerve injury, or hemidiaphragm dysfunction * Severe COPD, restrictive lung disease, or advanced parenchymal lung disease * Preoperative home oxygen therapy or CPAP/BiPAP/home mechanical ventilation * Conversion to open surgery (laparoscopic → open) * Hemodynamic instability preoperatively or intraoperatively; emergency/complicated surgery * Factors preventing ultrasound assessment (e.g., marked upper abdominal gas, large scar/wound, severe subcutaneous edema) * Same-day discharge cases with \<24-hour observation * Inability to complete measurements (e.g., severe cognitive impairment, poor cooperation, severe pain preventing measurement) * Incomplete data not compatible with the 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

diaphragmatic excursion (ΔDE) and postoperative hypoxemia

Timeframe: Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).

Trial details

NCT IDNCT07332728

SponsorIstinye University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-15

Contact for this trial

ilke dolgun

+905555485632 ilkeser2004@gmail.com

View on ClinicalTrials.gov More Perioperative Diaphragmatic Excursion trials