Difficult IntubationNCT06247631
STOP-Bang Questionnaire: A Predictor of Obstructive Sleep Apnea and Difficult Mask/Intubation?
An observational study of Difficult Intubation and Airway Disease, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. Obstructive sleep apnea syndrome (OSAS) is a warning sign of difficult airway management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Difficult Intubation, Airway Disease
- What is being tested?
- STOP BANG
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 10 Jul 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: Patients between the ages of 18-65, ASA 1-3, who will undergo thoracic surgery at the Ankara Atatürk Sanatorium Training and Research Hospital of the University of Health Sciences will be included in the study.
Who may be able to join
- Patient undergoing thoracic surgery
- 18-65 years old
- ASA 1-3
Who cannot join
- Having a history of obstructive sleep apnea syndrome,
- Having a history of previous head and neck surgery/radiotherapy,
- Patients who did not agree to participate in the study
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, 1 recruiting
- Recruiting
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
Ali ALAGÖZ, professor, 5079193765 ext. +9, mdalagoz@gmail.com
Onur KÜÇÜK, specialist
About this study
Official title: Can the STOP-Bang Questionnaire Predict Obstructive Sleep Apnea and Difficult Mask/Intubation in Patients Scheduled for Thoracic Surgery? Prospective Observational Study
Difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. Obstructive sleep apnea syndrome (OSAS) is a warning sign of difficult airway management. Polysomnography is the gold standard for diagnosis of this syndrome, but the STOP-BANG questionnaire is the preferred screening test. In this study, we wanted to find an answer to the question How successful is the STOP-BANG questionnaire in screening for obstructive sleep apnea syndrome (OSAS) in predicting OSAS, difficult mask and difficult intubation in patients undergoing thoracic surgery?
- Conditions
- Difficult Intubation, Airway Disease
- Being tested
- STOP BANG
- Keywords
- difficult intubation, difficult mask, Obstructive Sleep Apnea Syndrome, STOP-BANG, thoracic surgery
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP BANGOther
Also called STOP-Bang Questionnaire
The STOP-Bang Questionnaire is intended to give physicians an easy-to-use tool to identify people who might have obstructive sleep apnea (OSA). The questionnaire consists of eight yes-or-no questions based on the major risk factors for OSA. A STOP-Bang score of 2 or less is considered low risk, and a score of 5 or more is high risk for having either moderate or severe OSA. For people who score 3 or 4, doctors may need to perform further assessment to determine how likely they are to have OSA.
| Study group | Role | What they receive |
|---|---|---|
| Control | Easy airway: unassisted mask ventilation, ventilation without the need for an airway, achieving oxygen saturation above 90% during mask ventilation, and unassisted intubation with less than three attempts. Receives: Other: STOP BANG | |
| Difficult airway | Difficult airway: assisted mask ventilation, need for airway during ventilation, oxygen saturation falling below 90% during mask ventilation, assisted intubation, intubation attempt three and above Receives: Other: STOP BANG |
What is being measured
The primary outcome is the main question the study is designed to answer.
STOP-BANG questionnaire
A STOP-Bang score of 2 or less is considered low risk, and a score of 5 or more is high risk for having either moderate or severe obstructive sleep apnea (OSA). For people who score 3 or 4, doctors may need to perform further assessment to determine how likely they are to have OSA.
Measured: 1 month (1 time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start10 Jan 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Alagoz, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Ali ALAGÖZ, professor, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247631
- Sponsor's protocol ID
- E-53610172-799-213190410
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the STOP-Bang Questionnaire Predict Obstructive Sleep Apnea and Difficult Mask/Intubation in Patients Scheduled for Thoracic Surgery? Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06247631
- Acronym / sponsor ID
- E-53610172-799-213190410
- Conditions
- Difficult Intubation, Airway Disease
- Keywords
- difficult intubation, difficult mask, Obstructive Sleep Apnea Syndrome, STOP-BANG, thoracic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 8 Feb 2024 (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.
Difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. Obstructive sleep apnea syndrome (OSAS) is a warning sign of difficult airway management. Polysomnography is the gold standard for diagnosis of this syndrome, but the STOP-BANG questionnaire is the preferred screening test. In this study, we wanted to find an answer to the question How successful is the STOP-BANG questionnaire in screening for obstructive sleep apnea syndrome (OSAS) in predicting OSAS, difficult mask and difficult intubation in patients undergoing thoracic surgery?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: STOP BANGEasy airway: unassisted mask ventilation, ventilation without the need for an airway, achieving oxygen saturation above 90% during mask ventilation, and unassisted intubation with less than three attempts. |
| Difficult airway | – | Other: STOP BANGDifficult airway: assisted mask ventilation, need for airway during ventilation, oxygen saturation falling below 90% during mask ventilation, assisted intubation, intubation attempt three and above |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-65, ASA 1-3, who will undergo thoracic surgery at the Ankara Atatürk Sanatorium Training and Research Hospital of the University of Health Sciences will be included in the study.
Key inclusion criteria (3 listed)
- Patient undergoing thoracic surgery
- 18-65 years old
- ASA 1-3
Key exclusion criteria (3 listed)
- Having a history of obstructive sleep apnea syndrome,
- Having a history of previous head and neck surgery/radiotherapy,
- Patients who did not agree to participate 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 |
|---|---|---|
| STOP BANGAlso: STOP-Bang QuestionnaireThe STOP-Bang Questionnaire is intended to give physicians an easy-to-use tool to identify people who might have obstructive sleep apnea (OSA). The questionnaire consists of eight yes-or-no questions based on the major risk factors for OSA. A STOP-Bang score of 2 or less is considered low risk, and a score of 5 or more is high risk for having either moderate or severe OSA. For people who score 3 or 4, doctors may need to perform further assessment to determine how likely they are to have OSA. | Other | Control, Difficult airway |
Primary outcome
STOP-BANG questionnaire
Time frame: 1 month (1 time)
A STOP-Bang score of 2 or less is considered low risk, and a score of 5 or more is high risk for having either moderate or severe obstructive sleep apnea (OSA). For people who score 3 or 4, doctors may need to perform further assessment to determine how likely they are to have OSA.
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 30 Jan 2025.
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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.
Ali ALAGÖZ, professor principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
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 Difficult Intubation and Airway Disease, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 30 Jan 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 Ali ALAGÖZ, professor (5079193765 ext. +9, mdalagoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STOP-BANG questionnaire (time frame: 1 month (1 time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.