| CTRI Number |
CTRI/2024/04/065620 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Done To Assess Different Parameters In Predicting Difficult Airway Management In Pediatric Population |
|
Scientific Title of Study
|
A Comparative Evaluation Of Predictors Of Difficult Airways In Pediatric Population Using Various Bedside Anthropometric Parameters. 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 |
Swathi JR |
| Designation |
PG student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Anesthesiology Department
3rd floor
Victoria Hospital
Bangalore Medical College and Research Institute
KR road Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
8971844952 |
| Fax |
|
| Email |
swathijr477@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendra BS |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Anesthesiology Department
3rd floor
Victoria Hospital
Bangalore Medical College And Research Institute
KR road Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9902360703 |
| Fax |
|
| Email |
bsrags@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghavendra BS |
| Designation |
Associate Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Anesthesiology Department
3rd floor
Victoria Hospital
Bangalore Medical College and Research Institute
KR road Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9902360703 |
| Fax |
|
| Email |
bsrags@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute
KR road Bangalore Karnataka India 560002 |
|
|
Primary Sponsor
|
| Name |
Swathi JR |
| Address |
Anesthesiology Department
3rd floor
Victoria Hospital
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,
KR road Bangalore 560002 |
| Type of Sponsor |
Government 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 Swathi JR |
Victoria Hospital |
3rd floor, anesthesiology department victoria hospital
KR road bangalore 560002
Bangalore
KARNATAKA |
8971844952
swathijr477@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Bangalore Medical College and Research Institiute |
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 |
0.00 Day(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients with weight less than 20 kilogram
In non syndromic patients undergoing elective general anesthesia with endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
Weight more than 20
Craniofacial deformities
Patients with syndromic features
Refusal to give consent
Neck swellings |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the ratio of Frontal Plane Chin Distance to Weight and ratio of Thyro Mental Distance to Weight in predicting Difficult Laryngoscopy and Difficult Intubation |
before induction of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate weight age to predict Difficult Laryngoscopy & Difficult Intubation |
at the time of laryngoscopy & intubation at the time of induction of anesthesia |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
08/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/02/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [swathijr477@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 01-07-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
this study is conducted to evaluate the efficacy of the anthropometric parameters in predicting difficult intubation in pediatric population who are non syndromic with no airway pathology undergoing elective general anesthesia
Primary outcome to evaluate the ratio of Frontal Plane Chin Distance to Weight and ratio of Thyromental Distance to Weight to predict difficult laryngoscopy and intubation
Secondary outcome to evaluate if age weight and thyromental distance parameters in predicting difficult laryngoscopy and intubation
all the parameters measured will be recorded preoperatively and before induction and compared with Cormack Lahane grading for difficult laryngoscopy and intubation difficulty score for difficult intubation and categorized accordingly
|