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NCT Number: NCT07332728

Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

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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Key information

Conditions

Perioperative Diaphragmatic Excursion

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard perioperative care with observational diaphragm ultrasonography

Other

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.

Primary outcomes

diaphragmatic excursion (ΔDE) and postoperative hypoxemia

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

Association between perioperative change in diaphragmatic excursion (ΔDE) and postoperative hypoxemia, defined as SpO₂ < 92% and/or a clinically significant decrease in the SpO₂/FiO₂ ratio.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Prospective Observational Evaluation of the Association Between Perioperative Changes in Diaphragmatic Excursion and Postoperative Oxygenation and Hypoxemia in Patients Undergoing Laparoscopic Cholecystectomy

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 12, 2026
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.