| CTRI Number |
CTRI/2022/05/042531 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
12/05/2022 |
| 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 Clinical Trial To Study The Efficacy Of Two Larnygoscopes, C-Mac And Macintosh Laryngoscope In Children With Cervical Spine Injury |
|
Scientific Title of Study
|
Comparison Of Endotracheal Intubation Time Between C-Mac And Macintosh Laryngoscope In Simulated Unstable Cervical Spine In Paediatric Patients: A Randomised Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhumika Kalra |
| Designation |
Assistant Professor |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, Delhi |
| Address |
Room no.2,
Ot complex,2nd floor
Department of Anaesthesia,
Chacha Nehru Bal Chikitsalaya, Raja Ram Kohli Marg,
Geeta Colony,
Delhi 110031
C 209,
Prashant vihar,
Delhi-110085
East
DELHI
110031
India |
| Phone |
9810847992 |
| Fax |
|
| Email |
bhumikakalra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Bansal |
| Designation |
Fellow in Paediatric Anaesthesia |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, Delhi |
| Address |
Room no. 1,
Ot complex, 2nd floor
Department of Anaesthesia
Chacha Nehru Bal Chikitsalaya,
Raja Ram Kohli Marg,
Geeta Colony,
Delhi 110031
East
DELHI
110085
India |
| Phone |
09873888950 |
| Fax |
|
| Email |
docneha999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Bansal |
| Designation |
Fellow in Paediatric Anaesthesia |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, Delhi |
| Address |
Room no. 1,
Ot complex, 2nd floor
Department of Anaesthesia
Chacha Nehru Bal Chikitsalaya,
Raja Ram Kohli Marg,
Geeta Colony,
Delhi 110031
East
DELHI
110085
India |
| Phone |
09873888950 |
| Fax |
|
| Email |
docneha999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chacha Nehru Bal Chikitsalaya,
Raja Ram Kohli Marg,
Geeta Colony,
Delhi 110031 |
|
|
Primary Sponsor
|
| Name |
DR BHUMIKA KALRA |
| Address |
C – 209
Prashant Vihar
Delhi - 110085 |
| Type of Sponsor |
Other [Assistant Professor at Chacha Nehru Bal Chikitsalaya] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR AIKTA GUPTA |
2/30, Malviya Nagar, Delhi - 110017 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhumika Kalra |
CHACHA NEHRU BAL CHIKITSALAYA |
Ot A,B,C
Ot complex, 2nd floor
Department of Anaesthesia
Chacha Nehru Bal Chikitsalaya, Raja Ram Kohli Marg,
Geeta Colony,
Delhi 110031
East
DELHI |
9810847992
bhumikakalra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Chacha Nehru Bal Chikitsalya, Geeta Colony, Delhi ( ECR/1059/Inst/DL/2018) |
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 |
| Intervention |
C-MAC Videolaryngoscope |
The C-MAC video laryngoscope system (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) is the latest generation videolaryngoscope with a camera providing an 80° angle of view and a light source which is recessed from the tip of the blade. This portable videolaryngoscope along with other blades, comes with a modified Macintosh blade made of steel, the CMOS digital camera and high power LED hence providing both direct and indirect visualization of the glottic structures. |
| Comparator Agent |
Macintosh Laryngoscope |
Macintosh laryngoscope is the standard laryngoscope providing direct glottic view
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status grade I and II
Children aged 1-12 years undergoing elective or emergency surgery requiring general anaesthesia with orotracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway
Children with known metabolic disease
Children with uncontrolled reactive airway disease |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total duration of successful intubation procedure (Time to best glottic view + Time to intubate) |
at laryngoscopy and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Cormack Lehane grading during first attempt at laryngoscopy and the best laryngoscopic view obtained
2. First intubation success rate and total number of attempts required
3. Number of airway optimisation maneuvers applied
4. Hemodynamic responses
5. Number of episodes of complications
6. Ease of insertion of laryngoscope blade
|
during laryngoscopy and intubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/05/2022 |
| 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="0"
Months="6"
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 - 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
- Who will be able to view these files?
Response - Anyone
- 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 [Docneha999@gmail.com ].
- For how long will this data be available start date provided 16-05-2022 and end date provided 31-12-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is a hospital-based, prospective, randomized, parallel group, active controlled, open labelled trial comparing endotracheal intubation time between C-Mac and Macintosh laryngoscope in paediatric patients with simulated unstable cervical spine. The primary objective is to compare the total duration taken during the successful intubation with C-Mac videolaryngoscope with the total duration of time taken during the intubation procedure with Macintosh laryngoscope and the secondary objectives are to compare glottic views obtained on laryngoscopy during first attempt and after applying external laryngeal manipulation maneuver in the above two groups, to compare first intubation attempt success rate, number of intubation attempts, number of airway optimisation maneuvers required and ease of insertion of blade in the above two group and to compare incidence of complications, if any (desaturation, esophageal intubation, trauma) during intubation procedure in the above two groups.
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