- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06247631
STOP-Bang Questionnaire: A Predictor of Obstructive Sleep Apnea and Difficult Mask/Intubation?
February 7, 2024 updated by: Ali Alagoz, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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?
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali ALAGÖZ, professor
- Phone Number: +9 5079193765
- Email: mdalagoz@gmail.com
Study Locations
-
-
Keçiören
-
Ankara, Keçiören, Turkey, 06290
- Recruiting
- Ankara Atatürk Sanatorium Training and Research Hospital
-
Contact:
- Ali ALAGÖZ, professor
- Phone Number: +9 5079193765
- Email: mdalagoz@gmail.com
-
Sub-Investigator:
- Onur KÜÇÜK, specialist
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Patient undergoing thoracic surgery
- 18-65 years old
- ASA 1-3
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
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
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month (1 time)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ali ALAGÖZ, professor, Ankara Atatürk Sanatorium Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2024
Primary Completion (Estimated)
June 10, 2024
Study Completion (Estimated)
August 10, 2024
Study Registration Dates
First Submitted
January 22, 2024
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 8, 2024
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-53610172-799-213190410
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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