| CTRI Number |
CTRI/2025/03/082556 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational comparitive study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Which is better in predicting difficult intubation - acromio-axillo-suprasternal notch index or ratio of neck circumference to thyromental distance |
|
Scientific Title of Study
|
Comparison of acromio-axillo-suprasternal notch index with ratio of neck circumference to thyromental distance in predicting difficult intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/NEW/INST/2022/KA/0174 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithya Ramachandran |
| Designation |
Junior Resident |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy,P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8884586420 |
| Fax |
|
| Email |
nithya02m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ananda Bangera |
| Designation |
Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy,P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845278880 |
| Fax |
|
| Email |
anandabangera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananda Bangera |
| Designation |
Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy,P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845278880 |
| Fax |
|
| Email |
anandabangera@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy,P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
Nithya Ramachandran |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Medical Academy,P.O. Nityanandanagar, Deralakatte, Mangaluru, Karnataka 575018 |
| 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 Ananda Bangera |
K S Hegde Hospital |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA |
9845278880
anandabangera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC K S HEGDE MEDICAL ACADEMY |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years scheduled to undergo elective surgery under general endotracheal anaesthesia
Adults belonging to ASA physical status (ASA PS)I,II & III |
|
| ExclusionCriteria |
| Details |
Patients with obvious pathological condition in and around the mouth and neck
Restricted mouth opening
Pregnant ladies
Patients requiring rapid sequence intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| predictive accuracy(sensitivity, apecificity and predictive value) of AASI and NC to TMD ration in identifying difficult intubation, validated against Cormack-Lehane grade or intubation difficulty score(IDS) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sensitivity, specificity, correlation with other predictive tools. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
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)
|
31/03/2025 |
| 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="0"
Months="5"
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
|
Title: Comparison of acromio-axillo-suprasternal notch index with ratio of neck circumference to thyromental distance n predicting difficult intubation This prospective observational study aims to compare the effectiveness of the acromio-axillo-suprasternal notch index and neck circumference to thyromental distance ratio in predicting difficult intubation in adult surgical patients. Preoperative assessments will include age, sex, surgery, ASA status, height, weight, BMI, mouth opening, mallampati class, temoromandibular joint, sternomental distance, hyomental distance, upper lip bite test, inter incisor gap, thyromental distance , neck circumference, AASI, CL grading, IDS score. The study seeks to determine the sensitivity, specificity and predictive values of these indices for identifying patients at risk of difficult intubation, providing valuable insights for improving airway management strategies.
|