Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Perioperative Diaphragmatic Excursion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard perioperative care with observational diaphragm ultrasonography

No therapeutic intervention is applied in this study. All patients receive standard perioperative anesthesia and surgical care according to institutional routine. Diaphragmatic excursion is assessed non-invasively using ultrasonography in the preoperative period and at 15 minutes postoperatively in the post-anesthesia care unit. Oxygenation parameters and respiratory variables are recorded for observational analysis only.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No