Oxygen DeficiencyNCT07188649
Postoperative SpO₂/FiO₂ in Obese and Non-Obese Patients: Role of STOP-BANG
An observational study of Oxygen Deficiency, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- oxygen deficiency
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2025to 15 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Early Postoperative SpO₂/FiO₂ Ratio in Obese and Non-Obese Patients Undergoing Laparoscopic Surgery in the Reverse Trendelenburg Position: Evaluation Together With the STOP-BANG Score
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.
- Conditions
- Oxygen Deficiency
- Being tested
- oxygen deficiency
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen deficiencyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| obese | BMI ≥ 35 Receives: Behavioral: oxygen deficiency | |
| control | BMI < 35 Receives: Behavioral: oxygen deficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen level
SpO₂/FiO₂ ratio
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start25 Sep 2025 (estimated)
- Primary completion25 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188649
- Sponsor's protocol ID
- hulusi tez
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 288524735. 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative SpO₂/FiO₂ Ratio in Obese and Non-Obese Patients Undergoing Laparoscopic Surgery in the Reverse Trendelenburg Position: Evaluation Together With the STOP-BANG Score
- ClinicalTrials.gov ID
- NCT07188649
- Acronym / sponsor ID
- hulusi tez
- Conditions
- Oxygen Deficiency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 25 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese | – | Behavioral: oxygen deficiencyBMI ≥ 35 |
| control | – | Behavioral: oxygen deficiencyBMI < 35 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen deficiencyThe 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. | Behavioural | control, obese |
Primary outcome
oxygen level
Time frame: 4 months
SpO₂/FiO₂ ratio
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Results publication: PubMed 28852473Michael 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.
- Results publication5. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Deficiency, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen level (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07188649, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.