NCT06247631

Brief 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. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jan 2024Jul 2026

Study Start

First participant enrolled

January 10, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Expected
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

January 22, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

difficult intubationdifficult maskObstructive Sleep Apnea SyndromeSTOP-BANGthoracic surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month (1 time)

Study Arms (2)

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.

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

Other: STOP BANG

Interventions

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.

Also known as: STOP-Bang Questionnaire
ControlDifficult airway

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patient undergoing thoracic surgery
  • years old
  • ASA 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ali ALAGÖZ, professor

    Ankara Ataturk Sanatorium Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali ALAGÖZ, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiology and reanimation, Principal Investigator, Specialist Doctor

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 8, 2024

Study Start

January 10, 2024

Primary Completion

December 10, 2025

Study Completion (Estimated)

July 10, 2026

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations