| CTRI Number |
CTRI/2024/05/067504 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
To Assess The Maximum Condyle Tragus Distance As A Predictor Of Difficult Airway |
|
Scientific Title of Study
|
To Assess The Maximum Condyle Tragus Distance As A Predictor Of Difficult Airway |
| 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 Rinita Ann John |
| Designation |
Postgraduate resident |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College, Mangalore, Lighthouse Hill Road, Karnataka, 575001
Department of Anaesthesiology
Kasturba Medical College, Mangalore, Lighthouse Hill Road, Karnataka, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9544852288 |
| Fax |
|
| Email |
rinitarockz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Y V |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College, Mangalore, Lighthouse Hill Road, Karnataka, 575001
Department of Anaesthesiology,
Kasturba Medical College, Mangalore, Lighthouse Hill Road, Karnataka, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845085108 |
| Fax |
|
| Email |
suresh.yv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Y V |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Mangalore, Lighthouse Hill Road, Karnataka, 575001
Department of Anaesthesiology,
Kasturba Medical College, Mangalore, Lighthouse Hill Road, Karnataka, 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845085108 |
| Fax |
|
| Email |
suresh.yv@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education Manipal, Dakshina Kannada, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Rinita Ann John |
| Address |
Department of Anaesthesia, Kasturba Medical College, Lighthouse Hill Road, Mangalore, Karnataka, 575001 |
| 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 Rinita Ann John |
Kasturba Medical College Hospitals |
Department of Anaesthesiology,
Kasturba Medical College, Mangalore, Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA |
9544852288
rinitarockz@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: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders undergoing elective surgeries under general anaesthesia.
2. Patients of ASA 1, 2 and 3 category |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patient with anatomical craniofacial abnormality
3. oral malignancy and neck swelling
4. Patient with history of mandible dislocations
5. Edentulous patient
6. Pregnant females |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Condylar tragus distance
2. Cormack Lehane grading |
Preanesthetic check up
Elective intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of intubation based on
Number of attempts
Number of operators
Alternative techniques like bougie, video laryngoscope, fiberoptic intubation used or not
External laryngeal pressure applied or not |
elective intubation |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
01/07/2024 |
| 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="0"
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
|
Airway assessment is one of the most crucial steps of a preanesthetic evaluation. It will help us assess the facial features and help maintain breathing during surgical procedures. Predicting difficult airway will help us manage and prevent complications during the procedure. Condyle Tragus maximum distance measures the maximum interval between the condyle of mandible and the tragus of the ear with mouth wide open. This is an indirect indicator of the temporomandibular joint. The purpose of this study is to assess the efficacy of condyle tragus maximum distance and to compare the accuracy of this measure with standard parameters like Mallampati score, upper lip bite test and thyromental distance in predicting difficult airway in all patients undergoing elective surgeries under general anesthesia.
|