| CTRI Number |
CTRI/2024/04/065144 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study in adults wherein distance from the front of ear to the joint of the jaw bone is measured to predict any difficulty in passing a tube into a persons windpipe during general anaesthesia |
|
Scientific Title of Study
|
Evaluation of maximum condyle tragus distance a predictor of difficult airway management |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namita Anne |
| Designation |
Senior Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesia 2nd floor MS Ramaiah Hospital New Bel Road Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9741993094 |
| Fax |
|
| Email |
namita269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namita Anne |
| Designation |
Senior Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesia 2nd floor MS Ramaiah Hospital New Bel Road Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9741993094 |
| Fax |
|
| Email |
namita269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namita Anne |
| Designation |
Senior Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesia 2nd floor MS Ramaiah Hospital New Bel Road Bangalore
KARNATAKA
560054
India |
| Phone |
9741993094 |
| Fax |
|
| Email |
namita269@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College NeW Bel Road Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New Bel Road Bangalore 560054 |
| 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 Namita Anne |
MS Ramaiah Medical College Hospital |
Department of Anaesthesia 2nd floor MS Ramaiah Hospital New BEL Road Bangalore
Bangalore
KARNATAKA |
9741993094
namita269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MS Ramaiah Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patients presenting for elective surgery under general anaesthesia |
|
|
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 |
Adults aged 18 years-65 years undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Edentulous/ partial dentition
Maxillofacial surgeries
Uncooperative patients
Thyromental distance less than 6cm
Limited head and neck movement (less than 70 degrees)
Nasal intubation
Restricted mouth opening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cormacke-Lehane grading in relation to mandibular-condyle distance
Time of intubation in relation to mandibular-condyle distance |
At the time of intubation. 3 minutes after administration of muscle relaxant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
29/04/2024 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [namita269@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2066?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this prospective observational study, the condyle tragus distance will be evaluated to predict difficult airway management. Various conventional methods such as Mallampati classification, upper lip bite test and inter incisor distance will also be examined. The patient will be asked to open their mouth as wide as possible and the condyle tragus distance will be measured. The advantage of this study is assessment of the airway without exposure of the upper respiratory tract to the examiner. Commonly used airway assessment tests require the patient to remove their mask prior to examination, however this test doesn’t require the same. |