Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

January 12, 2026 updated by: İlke Dolgun, Istinye University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18-75 years undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care center. Eligible participants are patients without known diaphragmatic dysfunction or severe underlying pulmonary disease, in whom perioperative diaphragm ultrasonography and postoperative oxygenation measurements can be reliably performed. All participants provide written informed consent and receive standard perioperative care without any study-related intervention.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • serpil Diaphragm US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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