| CTRI Number |
CTRI/2021/09/036334 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE BETWEEN THREE INSTRUMENTS USED TO VISUALIZE VOCAL CORDS |
|
Scientific Title of Study
|
Comparison of ease of intubation with airtraq, miller, and macintosh laryngoscope blades in children- a prospepective randomised trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARUNIMA K G |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, HUBLI,
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, HUBLI,
Dharwad
KARNATAKA
580032
India |
| Phone |
08281705970 |
| Fax |
|
| Email |
arunima.kg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MADHURI KURDI |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, HUBLI
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, HUBLI
Dharwad
KARNATAKA
580032
India |
| Phone |
8147112765 |
| Fax |
|
| Email |
arunima.kg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MADHURI KURDI |
| Designation |
HAED OF THE DEPARTMENT |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, HUBLI,
DEPARTMENT OF ANAESTHESIOLOGY, KIMS, HUBLI,
Dharwad
KARNATAKA
580032
India |
| Phone |
8147112765 |
| Fax |
|
| Email |
arunima.kg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences, Vidhyanagar, Hubali, Karnataka, 580022 |
|
|
Primary Sponsor
|
| Name |
KIMS |
| Address |
KIMS, HUBLI, KARNATAKA |
| 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 Arunima K G |
KIMS |
Department of Anaesthesiology, KIMS,Hubli, Karnataka
Dharwad
KARNATAKA |
08281705970
arunima.kg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: J330||Polyp of nasal cavity, (3) ICD-10 Condition: J330||Polyp of nasal cavity, (4) ICD-10 Condition: J330||Polyp of nasal cavity, (5) ICD-10 Condition: J330||Polyp of nasal cavity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparing ease of intubation in 3 groups.
Patients intubated with airtraq ,Miller, macintosh |
Size of the Laryngoscope is based on the age and weight of the child |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
weight of 10 – 35 kg
Adequate mouth opening
Various elective surgerical procedures under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with active upper / lower respiratory tract infections
Risk of aspiration
Severe systemic disease
Anticipated difficult airway
Potiential and actual cervical spine injury
Laryngeal trauma
Hypoxia
Coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ease of intubation
ï‚·Intubation Difficulty Score (IDS),
Cormack–Lehane grade and Percentage of Glottic Opening (POGO)
Haemodynamic response |
Preinduction, Postintubation 0min, 1 min, 3 min, 5 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heamodynamic response |
0 min, 3 min, 5 min |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 2 |
|
Date of First Enrollment (India)
|
12/10/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of our study is to compare the ease of intubationof Airtraq laryngoscope blade with miller and macintosh laryngoscope blades of appropriate sizes in children undergoing elective surgeries under general anaesthsia
Objectives include: Time taken for intubation Ease of intubation Intubation Difficulty Score Cormack - L ehane grade and Percentage of Glottic Opening Haemodynamic response |