Airway ObstructionNCT05640856
Relationship Between STOP BANG Score and Airway Management
An observational study of Airway Obstruction and Obstructive Sleep Apnea, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction, Obstructive Sleep Apnea, Hypoxia
- What is being tested?
- intubation
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-65 to be intubated undergoing elective surgery
Who may be able to join
- American Society of Anesthesiologists (ASA) I-III
- Between 18-65 years old
- Volunteered to participate in the study
Who cannot join
- diagnosed with asthma, COPD, heart failure or coronary artery disease, OSAS
- morbidly obese (BMI>45 kg/m2),
- patients with a history of alcohol or drug addiction
- women in pregnancy or lactation
- allergic to the drugs used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Evaluation of Relationship Between Oxygen Reserve Index and Difficult Airway With Stop Bang Score
Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS. The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of OSAS according to the Stop Bang score.
- Conditions
- Airway Obstruction, Obstructive Sleep Apnea, Hypoxia
- Being tested
- intubation
- Keywords
- Oxygen Reserve Index, STOP BANG Score, Difficult Airway
- Medical subject headings
- Airway Obstruction, Sleep Apnea, Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubationProcedure or surgery
Endotracheal tube placement
| Study group | Role | What they receive |
|---|---|---|
| Group D | STOP BANG Score <3 Receives: Procedure: intubation | |
| Group Y | STOP BANG Score ≥ 3 Receives: Procedure: intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Oxygenation
prediction of desaturation by oxygen reserve index in patients with low and high risk of OSAS
Measured: up to intubation
Secondary outcomes (1)
Evaluation of difficult Airway
using mask-ventilation scale in patients with low and high risk of OSAS
Measured: up to intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Köksal, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640856
- Sponsor's protocol ID
- 2020-22/16
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alp ID, Koksal BG, Bollucuoglu K, Kucukosman G, Piskin O, Baytar C, Okyay RD, Ayoglu H. Evaluation of the relationship between the STOP-Bang score with oxygen reserve index and difficult airway: a prospective observational study. Braz J Anesthesiol. 2024 May-Jun;74(3):744453. doi: 10.1016/j.bjane.2023.07.010. Epub 2023 Jul 28.
PubMed 37517587
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Relationship Between Oxygen Reserve Index and Difficult Airway With Stop Bang Score
- ClinicalTrials.gov ID
- NCT05640856
- Acronym / sponsor ID
- 2020-22/16
- Conditions
- Airway Obstruction, Obstructive Sleep Apnea, Hypoxia
- Keywords
- Oxygen Reserve Index, STOP BANG Score, Difficult Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 7 Dec 2022 (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.
Nowadays, anesthetists may encounter many patients who are not diagnosed with obstructive sleep apnea syndrome (OSAS) to undergo elective surgery. Recognition of these patients by anesthesiologists and taking necessary precautions will significantly reduce perioperative complications and mortality. STOP-BANG is a questionnaire used to predict high risk of OSAS. The aim of our study is to evaluate the clinical use of the oxygen reserve index as an early warning of possible desaturation in patients with low and high risk of OSAS according to the Stop Bang score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | – | Procedure: intubationSTOP BANG Score <3 |
| Group Y | – | Procedure: intubationSTOP BANG Score ≥ 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 to be intubated undergoing elective surgery
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) I-III
- Between 18-65 years old
- Volunteered to participate in the study
Key exclusion criteria (5 listed)
- diagnosed with asthma, COPD, heart failure or coronary artery disease, OSAS
- morbidly obese (BMI>45 kg/m2),
- patients with a history of alcohol or drug addiction
- women in pregnancy or lactation
- allergic to the drugs used in the study
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 |
|---|---|---|
| intubationEndotracheal tube placement | Procedure or surgery | Group D, Group Y |
Primary outcome
Evaluation of Oxygenation
Time frame: up to intubation
prediction of desaturation by oxygen reserve index in patients with low and high risk of OSAS
1 secondary outcome
Evaluation of difficult Airway
Time frame: up to intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 37517587Alp ID, Koksal BG, Bollucuoglu K, Kucukosman G, Piskin O, Baytar C, Okyay RD, Ayoglu H. Evaluation of the relationship between the STOP-Bang score with oxygen reserve index and difficult airway: a prospective observational study. Braz J Anesthesiol. 2024 May-Jun;74(3):744453. doi: 10.1016/j.bjane.2023.07.010. Epub 2023 Jul 28.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Airway Obstruction and Obstructive Sleep Apnea, run by Zonguldak Bulent Ecevit 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 3 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: finished, as of the sponsor's last update on 7 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Oxygenation (time frame: up to intubation). 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 NCT05640856, which also lists 1 linked publication.
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 7 Dec 2022.