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Diaphragmatic Excursion Changes and Postoperative Oxygenation After Laparoscopic Cholecystectomy

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07332728
Enrollment
62
Registered
2026-01-12
Start date
2026-01-15
Completion date
2026-04-30
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Diaphragmatic Excursion

Brief summary

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

OTHERStandard 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.

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
diaphragmatic excursion (ΔDE) and postoperative hypoxemiaPreoperative 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.

Countries

Turkey (Türkiye)

Contacts

Primary Contactilke dolgun
ilkeser2004@gmail.com+905555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026