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Trial registered on ANZCTR


Registration number
ACTRN12625000276459
Ethics application status
Approved
Date submitted
21/03/2024
Date registered
10/04/2025
Date last updated
13/04/2025
Date data sharing statement initially provided
10/04/2025
Date results provided
10/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining the possibility of difficult intubation in adult patients to be applied to general anesthesia with obstructive sleep apnea screening tests
Scientific title
Comparison of the effectiveness of obstructive sleep apnea screening tests in determining the possibility of difficult intubation in adult patients to be applied to general anesthesia
Secondary ID [1] 311577 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult airway 333055 0
Obstructive sleep apnea 333056 0
Condition category
Condition code
Respiratory 329737 329737 0 0
Sleep apnoea
Anaesthesiology 329738 329738 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective observational study was conducted in the Operating Room of the Health Sciences University Ankara Training and Research Hospital, after the approval of the Clinical Research Ethics Committee of the University of Health Sciences Ankara Training and Research Hospital, dated 11.02.2021 and numbered E-93471371-514.10. All patients participating in the study were informed and their written consent was obtained. Patients who would undergo non-cardiac surgery and who would undergo general anesthesia were included in the study.
Patients were observed throughout the preoperative period and the intraoperative period starting with induction.

Age, gender, body weight, height, body mass index and ASA value were recorded in the preoperative evaluation of all patients. The oropharyngeal structures of all patients included in the study were examined and recorded according to the Modified Mallampati Score (opening the mouth completely in the sitting position, sticking out the tongue without making any sound).
While screening tests and anthropometric measurements (thyromental distance, neck circumference, waist circumference) were completed at the preoperative anesthesia evaluation 1 week before the surgical procedure, the Cormack-Lehane score was recorded during post-induction laryngoscopy. Thyromental distance was measured from the thyroid cartilage level with the tip of the chin while the head was in extension, without contacting the skin with a ruler. A thyromental distance of 6 cm or less was determined as a difficult airway criterion Neck circumference was measured at the level of the thyroid cartilage with the head in a neutral position. Difficult airway criterion was recorded as 40 cm and above . Waist circumference was measured from the mid-axillary line between the lowest point of the rib cage and the highest point of the iliac crest, with the patient in an upright position. Over 102 cm for men and 88 cm for women were considered associated with high risk.
Screening tests of the patients were completed during the preoperative anesthesia evaluation.Screening tests were completed 1 day before the preoperative period.
Intervention code [1] 328127 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337589 0
Primary outcome is to determine the value of use STOP-Bang Test used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [1] 337589 0
preoperative period before induction
Primary outcome [2] 340275 0
Primary outcome is to determine the value of use NoSAS Test used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [2] 340275 0
preoperative period before induction
Primary outcome [3] 340276 0
Primary outcome is to determine the value of use DES-OSA Score used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [3] 340276 0
preoperative period before induction
Secondary outcome [1] 432413 0
Secondary outcome is to compare the effectiveness of combined non-invasive screening tests used to evaluate the risk of OSA.
Timepoint [1] 432413 0
preoperative period before induction
Secondary outcome [2] 444442 0
Primary outcome is to determine the value of use No-Apnea Test used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [2] 444442 0
preoperative period before induction
Secondary outcome [3] 444443 0
Primary outcome is to determine the value of use OSA-50 Test used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [3] 444443 0
preoperative period before induction
Secondary outcome [4] 444444 0
Primary outcome is to determine the value of use P-SAP Score used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [4] 444444 0
preoperative period before induction
Secondary outcome [5] 444445 0
Primary outcome is to determine the value of use GOAL Questionnaire used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [5] 444445 0
preoperative period before induction
Secondary outcome [6] 444446 0
Primary outcome is to determine the value of use SPOSA Score used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [6] 444446 0
preoperative period before induction
Secondary outcome [7] 444447 0
Primary outcome is to determine the value of use Epworth Sleepiness Questionnaire used to evaluate the risk of OSA in determining the probability of difficult intubation
Timepoint [7] 444447 0
preoperative period before induction

Eligibility
Key inclusion criteria
Inclusion criteria:
Patients who will receive general anesthesia
Adults aged between 18 and 65 years
Patients with American Society of Anesthesiology (ASA) Score I-II-III
No history of previous obstructive sleep apnea (OSA)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Patients with facial abnormalies
Patients undergoing cardiothoracic surgery, head and neck surgery, neurosurgery and emergency surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Statistical analysis was performed using SPSS (Statistical Package for Social Sciences, Chicago, IL, USA) 20 software. Continuous variables were shown as mean ± standard deviation, while the number and percentage of cases were used as nominal data. Logistic Regression was applied for univariate analysis. The odds ratio and 95% confidence interval were calculated for each risk factor. The diagnostic performance of the risk of having low risk and high OSA discrimination was evaluated by calculating sensitivity, specificity, positive and negative predictive values, and accuracy at 3 cut-off points for OSA. A p value less than 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2021
Date of last participant enrolment
Anticipated
Actual
3/05/2021
Date of last data collection
Anticipated
Actual
7/05/2021
Sample size
Target
230
Accrual to date
Final
230
Recruitment outside Australia
Country [1] 26188 0
Turkey
State/province [1] 26188 0
Ankara

Funding & Sponsors
Funding source category [1] 315878 0
University
Name [1] 315878 0
Health Sciences University Ankara Training and Research Hospital
Country [1] 315878 0
Turkey
Primary sponsor type
University
Name
Health Sciences University Ankara Training and Research Hospital
Address
Country
Turkey
Secondary sponsor category [1] 318019 0
None
Name [1] 318019 0
Address [1] 318019 0
Country [1] 318019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314725 0
Clinical Research Ethics Committee of the University of Health Sciences Ankara Training and Research Hospital
Ethics committee address [1] 314725 0
Ethics committee country [1] 314725 0
Turkey
Date submitted for ethics approval [1] 314725 0
29/01/2021
Approval date [1] 314725 0
11/02/2021
Ethics approval number [1] 314725 0
E-93471371-514.10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132530 0
Dr Busra Ucar
Address 132530 0
Hacettepe, Ulucanlar st., No:89 Postal code: 06230 Altindag/Ankara Health Sciences University Ankara Training and Research Hospital
Country 132530 0
Turkey
Phone 132530 0
+90 506 431 33 30
Fax 132530 0
Email 132530 0
[email protected]
Contact person for public queries
Name 132531 0
Busra Ucar
Address 132531 0
Hacettepe, Ulucanlar st., No:89 Postal code: 06230 Altindag/Ankara Health Sciences University Ankara Training and Research Hospital
Country 132531 0
Turkey
Phone 132531 0
+90 506 431 33 30
Fax 132531 0
Email 132531 0
[email protected]
Contact person for scientific queries
Name 132532 0
Busra Ucar
Address 132532 0
Hacettepe, Ulucanlar st., No:89 Postal code: 06230 Altindag/Ankara Health Sciences University Ankara Training and Research Hospital
Country 132532 0
Turkey
Phone 132532 0
+90 506 431 33 30
Fax 132532 0
Email 132532 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The data will be shared on a case-by-case basis at the discretion of the principal investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data underlying published data will be shared upon request.

What types of analyses could be done with individual participant data?
• Data analyses will be approved to achieve aims outlined in a research proposal or for meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication and no anticipated end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access will be subject to approval by the principal investigator who can be contacted by emailing "[email protected]"

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21799Informed consent form    Study-related document.doc
21800Ethical approval    Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.