| CTRI Number |
CTRI/2024/06/068243 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| 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
|
Comparison of two laryngoscopes for intubation in lateral position |
|
Scientific Title of Study
|
Comparison of Macintosh Laryngoscope and C- Mac D-Blade video laryngoscope for intubation in lateral position- a prospective randomized controlled 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 |
Ganga R |
| Designation |
Junior resident |
| Affiliation |
PSG Institute of Medical Sciences & Research |
| Address |
Department of Anaesthesiology, PSG Institute of Medical Sciences & Research, Peelamedu Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
|
| Fax |
|
| Email |
gangareghupathy@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Renjith Viswanath |
| Designation |
Assistant Professor |
| Affiliation |
PSG Institute of Medical Sciences & Research |
| Address |
Department of Anaesthesiology, PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8089803837 |
| Fax |
|
| Email |
renjithv2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renjith Viswanath |
| Designation |
Assistant Professor |
| Affiliation |
PSG Institute of Medical Sciences & Research |
| Address |
Department of Anaesthesiology, PSG Institute of Medical Sciences & Research, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
8089803837 |
| Fax |
|
| Email |
renjithv2007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PSG Institute of Medical Sciences and Research |
| Address |
PSG Institute of Medical Sciences and Research
Avinashi Road
Peelamedu
Coimbatore
Tamilnadu
Pin code- 641004
India |
| 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 |
| Dr Renjith Viswanath |
PSG Institute of Medical Sciences and Research |
Department of Anaesthesiology
Second Floor, A block
PSG hospitals, Peelamedu, Coimbatore 641004
Coimbatore
TAMIL NADU |
8089803837
renjithv2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC PSGIMSR |
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 laryngoscope with D blade |
C-MAC laryngoscope with D blade for intubation in right lateral position |
| Comparator Agent |
Macintosh laryngoscope |
Macintosh laryngoscope for intubation in right lateral position |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status 1 or 2
Elective surgery under GA
Patients requiring Oral tracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult intubation or
difficult mask ventilation
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for glottis visualisation in seconds in the right lateral position |
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for intubation in seconds |
Single time point |
| Degree of difficulty of intubation using modified Intubation difficulty score (IDS) using both methods |
Single time point |
| Use of additional techniques like bougie for intubation in both techniques |
Single time point |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
- Who will be able to view these files?
Response (Others) - Researchers will be provided IPD on contacting the corresponding author after publication
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [renjithv2007@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 21-04-2026?
Response (Others) - AS PER THE INDICATED DATES
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The effectiveness of C- MAC video laryngoscope (D-blade) in intubation in the lateral position has not been studied. This study is a randomised controlled trial designed to compare the time taken for the visualization of the glottis in the right lateral position using a C- MAC D blade versus Macintosh laryngoscope. Other secondary outcomes are time taken for intubation, use of bougie, and intubation difficulty score. ASA 1 and 2 patients undergoing elective surgeries and planned for orotracheal intubation will be included in this study. The results of this study will help in choosing the correct laryngoscope for intubation in the lateral position, especially in emergencies. |