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Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

I

Istinye University

Status

Not yet enrolling

Conditions

Perioperative Diaphragmatic Excursion

Treatments

Other: Standard perioperative care with observational diaphragm ultrasonography

Study type

Observational

Funder types

Other

Identifiers

NCT07332728
serpil Diaphragm US

Details and patient eligibility

About

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.

Enrollment

62 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

ilke dolgun

Data sourced from clinicaltrials.gov

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