| CTRI Number |
CTRI/2025/08/093907 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing two simple tests to predict which patients may have difficulty with a breathing tube during surgery. |
|
Scientific Title of Study
|
Comparison between acromioaxillarysuperasternal notch index and wilson score for predicting difficult airway- a prospective observational study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Gandhi |
| Designation |
First Year postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Main OT complex,Room no.1,
13-A,Pondy-Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY
-605102
India |
| Phone |
8208768521 |
| Fax |
|
| Email |
sakshigandhi499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chinthavali Sujatha |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Sri Venkateshwaraa Medical
College Hospital and Research Centre, 13-A,Pondy-Villupuram Main
Road, Ariyur, Pudhucherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
sujathachinthavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chinthavali Sujatha |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology, Sri Venkateshwaraa Medical
College Hospital and Research Centre, 13-A,Pondy-Villupuram Main
Road, Ariyur, Pudhucherry.
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
sujathachinthavali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Sakshi Gandhi |
| Address |
epartment of Anaesthesiology, Main OT complex,Room no 1,
13-A,Pondy Villupuram Main Road, Sri Venkateshwaraa Medical
College Hospital and Research Centre, Ariyur, Puducherry.
Pondicherry
PONDICHERRY |
| 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 Sakshi Gandhi |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of
Anaesthesiology, Main
OT complex, Room
no.1,
13-A,Pondy-Villupuram
Main Road, Ariyur,
Pudhucherry-605102
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
8208768521
sakshigandhi499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult between 18-65years scheduled foe elective [planned]surgery under general anesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologist [ASA]gradeI,II,age between 18&65years, Patients scheduled for elective surgery under general anesthesia. |
|
| ExclusionCriteria |
| Details |
Patient requiring video layngoscopy& Fibroptic Bronchoscopy,History of head& neck surgery,patient with facial trauma,Patient with anticpatedsurgical airway requirement,Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the sensitivity and specificity of the Acromio–Axillo–Suprasternal Notch Index (AASNI) for predicting difficult airway in adult patients undergoing |
Day 0 - Assessed immediately during laryngoscopy and intubation procedure (single intraoperative assessment)" |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of the Wilson score for predicting difficult airway. |
From induction of anesthesia until successful endotracheal intubation during the same surgery (approximately 5–10 minutes intraoperatively). |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
10/09/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study compares two simple bedside tests-Acromioaxillary suprasternal notch index &wilson score to predict difficult airway. Adult patients aged 18-65 years who are scheduled for planned surgeries under general anesthesia will have their airway assessed using these two methods before surgery.During the operation,the ease or difficulty of inserting the breathing tube will be recorded.There are no risks for particpants , all standard anesthesia care is provided.The aim is to help anesthesiologists identify patients at risk for difficult airway in advance,improving safety during surgery. |