| CTRI Number |
CTRI/2025/12/098742 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the ability to predict the difficult airway by using various scores. |
|
Scientific Title of Study
|
Comparison of predictive ability of difficult airway by using NoSAS score,Berlin score and STOP Bang score. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaithra S |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology 2nd floor MS Ramaiah Medical College Hospital
MSRIT Post Banglore
Banglore
KARNATAKA
560054
India
Bangalore KARNATAKA 560054 India |
| Phone |
8861968102 |
| Fax |
|
| Email |
chaithrachethu125@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology 2nd floor MS Ramaiah Medical College Hospital
MSRIT Post Banglore
Banglore
KARNATAKA
560054
India
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology 2nd floor MS Ramaiah Medical College Hospital
MSRIT Post Banglore
Banglore
KARNATAKA
560054
India
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah medical College and hospital
Mathikere
Bengaluru 560054
Karnataka |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
MS Ramaiah Medical College New BEL Road MSRIT Post
Banglore 560054
Karnataka India |
| Type of Sponsor |
Private medical college |
|
|
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 Chaithra S |
MS Ramaiah Medical College Hospital |
Department of Anaesthesiology second floor MS Ramaiah Medical College Hospital NEW BEL Road
Bangalore
Karnataka Bangalore KARNATAKA |
8861968102
chaithrachethu125@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z759||Unspecified problem related to medical facilities and other health care, (2) ICD-10 Condition: Z759||Unspecified problem related to medical facilities and other health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient sechuled for elective surgeries requring general Anaesthesia.
Age above 18 years. |
|
| ExclusionCriteria |
| Details |
Patient with the history of difficulty airway.
Head and neck anomalies.
Obstetic patients.
Those undergoing awake fibre optic intubation.
Those for whom the primary choice for ventilation under general anaesthesia is laryngeal mask. Patients under 18 years of age.
Those requiring rapid sequence intubation.
Those scheduled for emergency surgeries.
Patients with the history of head and neck surgery,burns,trauma,radiotherapy.
Intubation in Accident and Emergency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of NoSAS ,Berlin,STOP Bang score in predicting difficult mask ventilation and difficult intubation. |
Preoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the cut off values of NoSAS score in predicting difficult mask ventilation & difficult intubation. |
Perioperative |
|
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="21" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The management of the airway during Anesthesia is critical part of patient care.Difficulty in mask ventilation and intubation poses risk of prolonged apnea,which can lead to hypoxia and potentially fatal outcome.The incidence of difficult face mask ventilation is 1.4 to 5.0% and the incidence of difficulty intubation with the conventional laryngoscope is 5 to 8%.Ensuring optimal oxygenation and ventilation in an anesthetized patient is a primary responsibility of anaesthesiologists and any difficulty in airway management is a significant concern.For every patient requiring tracheal intubation,an airway assessment must be performed to determine whether intubation can be safely achieved after the induction of general Anesthesia.This has lead to development of various scoring system to predict the likelihood of difficult intubation and difficult mask ventilation.The NoSAS score (Neck circumference,Obesity,Snoring,Age, and Sex) Berlin score and STOP Bang score have been developed.Each of these scoring system focuses on different clinical variables,but all aim to improve the patient outcome by identifying high risk individuals prior to anaesthesia. |