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Not yet recruiting NCT07332728

Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

— Observational Perioperative Diaphragmatic Excursion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard perioperative care with observational diaphragm ultrasonography.
Who it may be relevant to
Registry conditions: Perioperative Diaphragmatic Excursion. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • diaphragmatic excursion (ΔDE) and postoperative hypoxemia [Time frame: Preoperative baseline and 15 minutes after admission to the post-anesthesia care unit (PACU).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

Publications

  • Rustagi PS, Yadav A, Nellore SS. Ultrasonographic evaluation of diaphragmatic excursion changes after major laparoscopic surgeries in the Trendelenburg position under general anaesthesia: A prospective observational study. Indian J Anaesth. 2023 Nov;67(Suppl 4):S274-S280. doi: 10.4103/ija.ija_643_23. Epub 2023 Nov 21. PMID 38187984
  • Yao XY, Li HM, Sun BW, Zhang YY, Feng JG, Jia J, Liu L. Ultrasound assessment of diaphragmatic dysfunction in non-critically ill patients: relevant indicators and update. Front Med (Lausanne). 2024 Jun 18;11:1389040. doi: 10.3389/fmed.2024.1389040. eCollection 2024. PMID 38957305
  • Yan T, Yu Q, Li CQ, Xu ZZ, Ma JH, Xie M, Zhu SN, Wang DX, Li SL. Maximal inspiratory diaphragmatic ultrasound predicts postoperative pulmonary complications after upper abdominal surgery. Ann Intensive Care. 2025 Aug 18;15(1):121. doi: 10.1186/s13613-025-01531-2. PMID 40824343

Identifiers

NCT: NCT07332728 · serpil Diaphragm US

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗