HypoxemiaNCT07303205
Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery
An observational study of Hypoxemia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates whether the preoperative ROX index can predict early postoperative hypoxemia in patients undergoing bariatric surgery. Preoperative ROX measurements, along with ARISCAT and STOP-Bang scores, will be assessed for their association with hypoxemia occurring within the first… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- Preoperative ROX Index Assessment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2025to 1 Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients scheduled for elective bariatric surgery, including laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. All participants are obese (BMI ≥ 35 kg/m²) and evaluated preoperatively in the anesthesia clinic prior to surgery.
Who may be able to join
- Adults aged 18-65 years
- Scheduled for elective bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass)
- Body mass index (BMI) ≥ 35 kg/m²
- ASA physical status I-III
- Able and willing to provide written informed consent
Who cannot join
- Acute respiratory failure, pneumonia, or active pulmonary infection
- Receiving oxygen therapy or respiratory support (nasal cannula, CPAP, BiPAP, or high-flow oxygen) preoperatively
- Preoperative SpO₂ < 88% on room air
- Significant cardiac arrhythmia, severe heart failure (NYHA class III-IV), or hemodynamic instability
- Pregnancy, active malignancy, or current immunosuppressive therapy
- Inability to complete postoperative follow-up or early discharge before 12-hour assessment
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: Predictive Value of the Preoperative ROX Index for Early Postoperative Hypoxemia in Bariatric Surgery Patients: A Prospective Observational Cohort Study
This prospective observational study evaluates whether the preoperative ROX index can predict early postoperative hypoxemia in patients undergoing bariatric surgery. Preoperative ROX measurements, along with ARISCAT and STOP-Bang scores, will be assessed for their association with hypoxemia occurring within the first 12 postoperative hours.
- Conditions
- Hypoxemia
- Being tested
- Preoperative ROX Index Assessment
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative ROX Index AssessmentOther
Participants will undergo a preoperative assessment including measurement of the ROX index (SpO₂/FiO₂ divided by respiratory rate) before bariatric surgery. No treatment or study-related intervention will be applied; all perioperative care will follow routine clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Hypoxemia
Hypoxemia defined as SpO₂ < 92% or new oxygen requirement within the first postoperative hours.
Measured: Postoperative 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completion25 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303205
- Sponsor's protocol ID
- erkan rox indeksi
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. Erector Spinae Plane Block and its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Double-Blind Randomized Control Trial. Obes Surg. 2025 Dec;35(12):5228-5236. doi: 10.1007/s11695-025-08337-y. Epub 2025 Nov 4.
PubMed 41188672Wang X, Guo K, Sun J, Yang Y, Wu Y, Tang X, Xu Y, Chen Q, Zeng S, Wang L, Liu S. Semirecumbent Positioning During Anesthesia Recovery and Postoperative Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2416797. doi: 10.1001/jamanetworkopen.2024.16797.
PubMed 38941098Lee S, Hong H, Cho H, Lee SW, You AH, Kang HY, Park SW, Kim MK, Choi JH. Association between preoperative oxygen reserve index and postoperative pulmonary complications: a prospective observational study. Korean J Anesthesiol. 2025 Jun;78(3):224-235. doi: 10.4097/kja.24420. Epub 2025 Feb 17.
PubMed 40468628
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Preoperative ROX Index for Early Postoperative Hypoxemia in Bariatric Surgery Patients: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07303205
- Acronym / sponsor ID
- erkan rox indeksi
- Conditions
- Hypoxemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Dec 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.
This prospective observational study evaluates whether the preoperative ROX index can predict early postoperative hypoxemia in patients undergoing bariatric surgery. Preoperative ROX measurements, along with ARISCAT and STOP-Bang scores, will be assessed for their association with hypoxemia occurring within the first 12 postoperative hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients scheduled for elective bariatric surgery, including laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. All participants are obese (BMI ≥ 35 kg/m²) and evaluated preoperatively in the anesthesia clinic prior to surgery.
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Scheduled for elective bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass)
- Body mass index (BMI) ≥ 35 kg/m²
- ASA physical status I-III
- Able and willing to provide written informed consent
Key exclusion criteria (6 listed)
- Acute respiratory failure, pneumonia, or active pulmonary infection
- Receiving oxygen therapy or respiratory support (nasal cannula, CPAP, BiPAP, or high-flow oxygen) preoperatively
- Preoperative SpO₂ < 88% on room air
- Significant cardiac arrhythmia, severe heart failure (NYHA class III-IV), or hemodynamic instability
- Pregnancy, active malignancy, or current immunosuppressive therapy
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 |
|---|---|---|
| Preoperative ROX Index AssessmentParticipants will undergo a preoperative assessment including measurement of the ROX index (SpO₂/FiO₂ divided by respiratory rate) before bariatric surgery. No treatment or study-related intervention will be applied; all perioperative care will follow routine clinical practice. | Other | – |
Primary outcome
Early Postoperative Hypoxemia
Time frame: Postoperative 0-12 hours
Hypoxemia defined as SpO₂ < 92% or new oxygen requirement within the first postoperative hours.
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 24 Dec 2025.
- Results publication: PubMed 41188672Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. Erector Spinae Plane Block and its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Double-Blind Randomized Control Trial. Obes Surg. 2025 Dec;35(12):5228-5236. doi: 10.1007/s11695-025-08337-y. Epub 2025 Nov 4.
- Results publication: PubMed 38941098Wang X, Guo K, Sun J, Yang Y, Wu Y, Tang X, Xu Y, Chen Q, Zeng S, Wang L, Liu S. Semirecumbent Positioning During Anesthesia Recovery and Postoperative Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2416797. doi: 10.1001/jamanetworkopen.2024.16797.
- Results publication: PubMed 40468628Lee S, Hong H, Cho H, Lee SW, You AH, Kang HY, Park SW, Kim MK, Choi JH. Association between preoperative oxygen reserve index and postoperative pulmonary complications: a prospective observational study. Korean J Anesthesiol. 2025 Jun;78(3):224-235. doi: 10.4097/kja.24420. Epub 2025 Feb 17.
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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 Hypoxemia, 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 6 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 24 Dec 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?
Early Postoperative Hypoxemia (time frame: Postoperative 0-12 hours). 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 NCT07303205, which also lists 3 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 24 Dec 2025.