| CTRI Number |
CTRI/2021/06/034170 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
25/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
STOP-BANG Questionnaire to screen OSA in patients posted for surgery |
|
Scientific Title of Study
|
STOP-BANG Questionnaire as a screening tool for obstructive sleep apnoea in the surgical population: A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kajal Shetty |
| Designation |
Student |
| Affiliation |
Justice K S Hegde charitable Hospital deral |
| Address |
Department of Anaesthesia and OT technology Justice K S Hegde charitable Hospital Deralakatte Mangaluru
"Shiv din" nilaya opposite Karnataka Bank jeppu market Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8073814280 |
| Fax |
|
| Email |
kajalshetty98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kajal Shetty |
| Designation |
Student |
| Affiliation |
Justice K S Hegde charitable Hospital deral |
| Address |
Department of Anaesthesia and OT technology Justice K S Hegde charitable Hospital Deralakatte Mangaluru
"Shiv din" nilaya opposite Karnataka Bank jeppu market Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8073814280 |
| Fax |
|
| Email |
kajalshetty98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kajal Shetty |
| Designation |
Student |
| Affiliation |
Justice K S Hegde charitable Hospital deral |
| Address |
Department of Anaesthesia and OT technology Justice K S Hegde charitable Hospital Deralakatte Mangaluru
"Shiv din" nilaya opposite Karnataka Bank jeppu market Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8073814280 |
| Fax |
|
| Email |
kajalshetty98@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy |
|
|
Primary Sponsor
|
| Name |
Kajal Shetty |
| Address |
Department of Anaesthesia and OT technology Justice K S Hegde Hospital Deralakatte Mangaluru |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashmi Soori |
Justice K S Hegde Charitable Hospital |
Department of anesthesiology Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA |
8050152374
drrashmisoori@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients posted for elective surgery |
|
| ExclusionCriteria |
| Details |
Pediatric, Pregnant patients |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of OSA in subjects undergoing surgery using STOP-BANG Questionnaire |
12 - 24 hours prior to anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
In those patients undergoing general anaesthesia, to estimate incidence of difficult airway.
To correlate the incidence of difficult airway with higher STOP-BANG scores. |
During the induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
Final Enrollment numbers achieved (Total)= "174"
Final Enrollment numbers achieved (India)="174" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2021 |
| Date of Study Completion (India) |
31/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2021 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Majority of OSA is undiagnosed and carries perioperative risk during induction and recovery due to airway collapse. Screening OSA with STOP-BANG questionnaire may help us to be prepared for the airway complications helping us to minimize them. |