NCT07188649

Brief Summary

The aim of this study is to evaluate the effect of the Reverse Trendelenburg position on oxygenation (SpO₂/FiO₂ ratio) in the early postoperative period in patients undergoing laparoscopic surgery. In our study, obesity is considered as a comparative subgroup in terms of variability of this effect; additionally, the STOP-BANG score, which measures the risk of obstructive sleep apnea syndrome, is examined as an auxiliary indicator.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 16, 2025

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • oxygen level

    SpO₂/FiO₂ ratio

    4 months

Study Arms (2)

obese

BMI ≥ 35

Behavioral: oxygen deficiency

control

BMI \< 35

Behavioral: oxygen deficiency

Interventions

The aim of this study is to evaluate the effect of the Reverse Trendelenburg position on oxygenation (SpO₂/FiO₂ ratio) in the early postoperative period in patients undergoing laparoscopic surgery. In our study, obesity is considered as a comparative subgroup in terms of variability of this effect; additionally, the STOP-BANG score, which measures the risk of obstructive sleep apnea syndrome, is examined as an auxiliary indicator.

controlobese

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults over 18, ASA I-III patients, patients who give consent to participate, patients undergoing elective laparoscopic surgery (obesity surgery, cholecystectomy, umbilical hernia, etc.)

You may qualify if:

  • Patients over 18 years old
  • Patients who give consent to participate in the study
  • Patients who underwent elective laparoscopic cholecystectomy in Reverse Trendelenburg (30 degrees) position
  • ASA I-III patients
  • Patients with operation time \< 3 hours

You may not qualify if:

  • Patients under 18 years old
  • Patients who did not give consent
  • Patients with asthma, COPD, or known respiratory disease
  • Patients whose procedure could not be completed or who had missing data
  • Patients with general anesthesia duration \< 90 minutes will not be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • Michael Dunham C, Hileman BM, Hutchinson AE, Antonaccio T, Chance EA, Huang GS, Szmaj G, Calabro K, Bishop C, Schrickel TT. Evaluation of operating room reverse Trendelenburg positioning and its effect on postoperative hypoxemia, aspiration, and length of stay: a retrospective study of consecutive patients. Perioper Med (Lond). 2017 Aug 22;6:10. doi: 10.1186/s13741-017-0067-2. eCollection 2017.

  • 5. Pirenne S, Hans G, Leloup von Edelsberg S, Joris J. STOP-BANG but not BMI predicts postoperative obstructive apnea and hypoxemia after laparoscopic upper-abdominal surgery. University of Liège, Department of Anaesthesiology & Intensive Care, Belgium.

    RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. prof

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 23, 2025

Study Start

September 25, 2025

Primary Completion

January 25, 2026

Study Completion

February 15, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations