Postoperative HypoxemiaNCT07344103
Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery
An observational study of Postoperative Hypoxemia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Early postoperative hypoxemia is a frequent complication after elective ear, nose, and throat (ENT) surgery and may adversely affect recovery in the post-anesthesia care unit (PACU). Simple and non-invasive preoperative tools to identify patients at risk for early postoperative hypoxemia are limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Hypoxemia
- What is being tested?
- rox ındex
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 1 Apr 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: Adult patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective septorhinoplasty or endoscopic sinus surgery under general anesthesia will be included in this study. All participants will undergo standard preoperative assessment, including measurement of oxygen saturation and respiratory rate on room air, and will be monitored postoperatively in the post-anesthesia care unit (PACU) according to routine clinical practice.
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective septorhinoplasty or endoscopic sinus surgery
- Undergoing surgery under general anesthesia
- Ability to undergo preoperative measurement of oxygen saturation and respiratory rate on room air
- Provision of written informed consent
Who cannot join
- Age <18 years or >65 years
- ASA physical status III or higher
- Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, pulmonary hypertension, severe heart failure)
- Active respiratory tract infection in the preoperative period
- Body mass index (BMI) >35 kg/m²
- Requirement for long-term supplemental oxygen therapy
- Refusal or inability to provide informed consent
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: Association of the Preoperative ROX Index With Early Postoperative Hypoxemia in Adult Patients Undergoing Elective Septorhinoplasty and Endoscopic Sinus Surgery: A Prospective Observational Study
Early postoperative hypoxemia is a frequent complication after elective ear, nose, and throat (ENT) surgery and may adversely affect recovery in the post-anesthesia care unit (PACU). Simple and non-invasive preoperative tools to identify patients at risk for early postoperative hypoxemia are limited.
The ROX index, calculated using oxygen saturation, fraction of inspired oxygen, and respiratory rate, is an easily applicable bedside parameter that has been shown to predict respiratory deterioration in various clinical settings. However, its predictive value in the preoperative period for patients undergoing elective ENT surgery has not been well established.
This prospective observational study aims to evaluate the association between the preoperative ROX index measured on room air and early postoperative hypoxemia in adult patients undergoing elective septorhinoplasty or endoscopic sinus surgery under general anesthesia. Early postoperative hypoxemia will be defined as oxygen saturation below 92% or the need for supplemental oxygen at a flow rate of 4 L/min or higher within the first 30 minutes after PACU admission. The predictive performance of the ROX index will be assessed using receiver operating characteristic (ROC) analysis.
- Conditions
- Postoperative Hypoxemia
- Being tested
- rox ındex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rox ındexDiagnostic test
No intervention; observational study only.
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Hypoxemia
Early postoperative hypoxemia will be defined as an oxygen saturation (SpO₂) below 92% or the requirement for supplemental oxygen at a flow rate of 4 L/min or higher.
Measured: Within the first 30 minutes after admission to the post-anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion1 Apr 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 Postoperative 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
- NCT07344103
- Sponsor's protocol ID
- 324-2025
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khurshied S, Zahid MA, Babar A, Rafique MH, Khurshid N, Hussain A, Saif M. Effects of Nasal Packing on Patients' Post-operative Vital Signs. Cureus. 2024 Jun 18;16(6):e62616. doi: 10.7759/cureus.62616. eCollection 2024 Jun.
PubMed 39027799Xiong N, Nong Y, Yi Y. Meta-analysis of risk factors associated with postoperative hypoxemia in the postanesthesia care unit. Am J Transl Res. 2024 Oct 15;16(10):5787-5796. doi: 10.62347/LCKG5157. eCollection 2024.
PubMed 39544775
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Preoperative ROX Index With Early Postoperative Hypoxemia in Adult Patients Undergoing Elective Septorhinoplasty and Endoscopic Sinus Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07344103
- Acronym / sponsor ID
- 324-2025
- Conditions
- Postoperative Hypoxemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Jan 2026 (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.
Early postoperative hypoxemia is a frequent complication after elective ear, nose, and throat (ENT) surgery and may adversely affect recovery in the post-anesthesia care unit (PACU). Simple and non-invasive preoperative tools to identify patients at risk for early postoperative hypoxemia are limited.
The ROX index, calculated using oxygen saturation, fraction of inspired oxygen, and respiratory rate, is an easily applicable bedside parameter that has been shown to predict respiratory deterioration in various clinical settings. However, its predictive value in the preoperative period for patients undergoing elective ENT surgery has not been well established.
This prospective observational study aims to evaluate the association between the preoperative ROX index measured on room air and early postoperative hypoxemia in adult patients undergoing elective septorhinoplasty or endoscopic sinus surgery under general anesthesia. Early postoperative hypoxemia will be defined as oxygen saturation below 92% or the need for supplemental oxygen at a flow rate of 4 L/min or higher within the first 30 minutes after PACU admission. The predictive performance of the ROX index will be assessed using receiver operating characteristic (ROC) analysis.
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
- Adult patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective septorhinoplasty or endoscopic sinus surgery under general anesthesia will be included in this study. All participants will undergo standard preoperative assessment, including measurement of oxygen saturation and respiratory rate on room air, and will be monitored postoperatively in the post-anesthesia care unit (PACU) according to routine clinical practice.
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective septorhinoplasty or endoscopic sinus surgery
- Undergoing surgery under general anesthesia
- Ability to undergo preoperative measurement of oxygen saturation and respiratory rate on room air
Key exclusion criteria (7 listed)
- Age <18 years or >65 years
- ASA physical status III or higher
- Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, pulmonary hypertension, severe heart failure)
- Active respiratory tract infection in the preoperative period
- Body mass index (BMI) >35 kg/m²
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 |
|---|---|---|
| rox ındexNo intervention; observational study only. | Diagnostic test | – |
Primary outcome
Early Postoperative Hypoxemia
Time frame: Within the first 30 minutes after admission to the post-anesthesia care unit (PACU)
Early postoperative hypoxemia will be defined as an oxygen saturation (SpO₂) below 92% or the requirement for supplemental oxygen at a flow rate of 4 L/min or higher.
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 20 Jan 2026.
- Background: PubMed 39027799Khurshied S, Zahid MA, Babar A, Rafique MH, Khurshid N, Hussain A, Saif M. Effects of Nasal Packing on Patients' Post-operative Vital Signs. Cureus. 2024 Jun 18;16(6):e62616. doi: 10.7759/cureus.62616. eCollection 2024 Jun.
- Background: PubMed 39544775Xiong N, Nong Y, Yi Y. Meta-analysis of risk factors associated with postoperative hypoxemia in the postanesthesia care unit. Am J Transl Res. 2024 Oct 15;16(10):5787-5796. doi: 10.62347/LCKG5157. eCollection 2024.
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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 Postoperative 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 6 inclusion and 7 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 20 Jan 2026. 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: Within the first 30 minutes after admission to the post-anesthesia care unit (PACU)). 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 NCT07344103, 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 20 Jan 2026.