| CTRI Number |
CTRI/2021/06/034047 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
06/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
VIDEO LARYNGOSCOPY VERSUS DIRECT LARYNGOSCOPY IN PEDIATRIC PATIENTS |
|
Scientific Title of Study
|
COMPARISION OF VIDEOLARYNGOSCOPY TO DIRECT LARYNGOSCOPY FOR ENDOTRACHEAL INTUBATON WITH MACINTOSH BLADE 2 IN PEDIATRIC PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KANUKUNTLA SHRAVYA |
| Designation |
POST GRADUATE IN MD ANAESTHESIOLOGY |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANGALORE |
| Address |
Kasturba medical college mangalore 203, Light house hill road, Hampankatta, Mangalore, Karnataka 575001
KMC Hospital Attavar, Mangalore- 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9985196042 |
| Fax |
|
| Email |
shravya.kanukuntla95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUNIL B V |
| Designation |
ASSOCIATE PROFESSOR OF ANAESTHESIOLOGY DEPARTMENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANGALORE |
| Address |
Kasturba medical college mangalore 203, Light house hill road, Hampankatta, Mangalore, Karnataka 575001
KMC Hospital Attavar, Mangalore- 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KANUKUNTLA SHRAVYA |
| Designation |
POST GRADUATE IN MD ANAESTHESIOLOGY |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANGALORE |
| Address |
Kasturba medical college mangalore 203, Light house hill road, Hampankatta, Mangalore, Karnataka 575001
KMC Hospital Attavar, Mangalore- 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9985196042 |
| Fax |
|
| Email |
shravya.kanukuntla95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KASTURBA MEDICAL COLLEGE MANGALORE |
| Address |
203, Light House Hill Rd, Hampankatta, Mangalore, Karnataka 575001 |
| 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 |
| KANUKUNTLA SHRAVYA |
KASTURBA MEDICAL COLLEGE HOSPITALS |
SIXTH FLOOR, ANAESTHESIOLOGY DEPARTMENT, KMC HOSPITAL, NANDIGUDDA ROAD, ATTAVAR, MANGALURU, DAKSHIN KANNADA, KARNATAKA
Dakshina Kannada
KARNATAKA |
9985196042
shravya.kanukuntla95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE, KASTURBA MEDICAL COLLEGE, MANGALORE |
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 |
DIRECT LARYNGOSCPE |
TO COMPARE THE EASE AND TIME TAKEN IN SECONDS TO MINUTES FOR INTUBATION IN PEDIATRIC PATIENTS BETWEEN VIDEO LARYNGOSCOPY AND DIRECT LARYNGOSCOPY |
| Comparator Agent |
VIDEO LARYNGOSCOPE |
TO COMPARE THE EASE AND TIME TAKEN IN SECONDS TO MINUTES FOR INTUBATION IN PEDIATRIC PATIENTS BETWEEN VIDEO LARYNGOSCOPY AND DIRECT LARYNGOSCOPY |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for pediatric surgeries and requiring airway management |
|
| ExclusionCriteria |
| Details |
1. Difficult airway
2. Obese patients (BMI >95 percentile)
3. ASA>3
4. patients with congenital anamolies
5. Patients with altered coagulation parameters
6. Patients with cervical spine injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COMPARING THE EASE OF INTUBATION BETWEEN VIDEO LARYNGOSCOPY AND DIRECT LARYNGOSCOPY IN PEDIATRIC PATIENTS |
TIME TAKEN TO SECURE THE AIRWAY WITH AN ET tube in seconds to minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the pre and post intubation hemodynamics( Heart rate, Blood pressure, Saturation) |
Baseline, 1 min, 3 min, 5 min, 10 min |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
13/06/2021 |
| 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="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to compare the success of first attempt tracheal intubation between direct laryngoscope and video laryngoscope in pediatric patients of 2-8 years age group requiring airway management |