| CTRI Number |
CTRI/2021/07/034829 [Registered on: 14/07/2021] Trial Registered Prospectively |
| Last Modified On: |
12/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two
different types of video laryngoscopes (Airtraq optical laryngoscope and McGrath video laryngoscope) for intubation in children |
|
Scientific Title of Study
|
Airtraq optical laryngoscope versus McGrath video laryngoscope for endotracheal intubation in paediatric patients undergoing elective surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nity Naveenta Ekka |
| Designation |
post graduate student M.D. Anaesthesiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Department of Anaesthesiology
Bahadur Shah Zafar Marg
New Delhi
Maulana Azad Medical College
Department of Anaesthesiology
Bahadur Shah Zafar Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
9582290672 |
| Fax |
|
| Email |
nitynaveentaekka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bhadoria |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Department of Anaesthesiology
Bahadur Shah Zafar Marg
New Delhi
Maulana Azad Medical College
Department of Anaesthesiology
Bahadur Shah Zafar Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604213 |
| Fax |
|
| Email |
bhadoriap@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nity Naveenta Ekka |
| Designation |
post graduate student M.D. Anaesthesiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Department of Anaesthesiology
Bahadur Shah Zafar Marg
New Delhi
Maulana Azad Medical College
Department of Anaesthesiology
Bahadur Shah Zafar Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
9582290672 |
| Fax |
|
| Email |
nitynaveentaekka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 |
| 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 |
| Nity Naveenta Ekka |
Maulana Azad Medical College |
Bahadur Shah Zafar marg
New Delhi 110002
Central
DELHI |
9582290672
nitynaveentaekka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College |
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 |
airtraq optical laryngoscope versus Macgrath videolaryngoscopes |
ease of intubation will be compared for both the videolaryngoscopes. Time to intubate will be taken as the time from the entry of the device into the mouth till the appearance of the first square shaped capnograph. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children 2-8 yrs of age belonging to ASA I & II undergoing elective surgery under general anaesthesia
2. Modified Mallampati class I and II
|
|
| ExclusionCriteria |
| Details |
1. Inter-incisor gap ≤ 2.5cms
2. Hyper-reactive airway
3. Predicted difficult airway (orofacial deformities, oral cavity pathology, facial trauma, cervical spine pathology, suspected spine injury)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation Difficulty Score |
At the time of insertion, 2,4, 6, 8, 10 minutes after insertion of airway device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to intubate
2.Hemodynamic Response
3.Incidence of Complications |
- time interval between blade entry past the lips and appearance of first square capnograph
-Heart rate and Mean arterial pressure at 2 min interval for first 10 mins after intubation
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/07/2021 |
| 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="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
|
As anaesthesiologists we deal with airway every day and almost every case. Many cases of difficult tracheal intubation remain unrecognized until after induction of anaesthesia. Endotracheal intubation using direct laryngoscope is gold standard for securing a patient’s airway and is widely used. Video laryngoscopes ar relatively recent entrants in the field of laryngoscopes with the benefit of better glottic view. The paediatric Airtraq is a rigid optical laryngoscope which offers the advantage of better glottis display in neutral position. Designed to facilitate complete visualization of the airway throughout the process of intubation. The blade comprises of two channels, one channel acts as a conduit through which the tracheal tube is passed whilst the other contains a light source and a series of lenses and mirrors that reflect the image from the tip of the blade to the viewfinder at the proximal end of the scope. Image can be viewed through the viewfinder. The McGrath video laryngoscope is a non- channeled video laryngoscope with a Macintosh type blade which provides a view of glottis on the monitor. It consists of three main parts: handle, camera stick and blade. A monitor is mounted on top of the handle allowing the operator to focus into the anatomical detail with clarity. Here we aim to compare Airtraq with McGrath laryngoscope for endotracheal intubation in paediatric patients undergoing elective surgery. |