| CTRI Number |
CTRI/2025/02/080560 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare the intubation characteristics using two different methods video and mcCoy laryngoscope in patients undergoing General anaesthesia |
|
Scientific Title of Study
|
Evaluation of intubation characteristics of video larynngoscope and mcCoy laryngoscope in patients undergoing general anesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Zeb Raza |
| Designation |
Junior Resident in department of Anaesthesiology |
| Affiliation |
Gandhi Medical College Bhopal |
| Address |
Operation theatre,2nd floor, Department of anaesthesiology,Gandhi medical college,Bhopal
MADHYA PRADESH
INDIA
GMC CAMPUS BHOPAL
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7505738098 |
| Fax |
|
| Email |
sahil.naqvi91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Awasya |
| Designation |
Professor in department of Anaesthesiology |
| Affiliation |
Gandhi Medical College Bhopal |
| Address |
Operation theatre,2nd floor, Department of Anaesthesiology,Gandhi medical college,Bhopal
Gandhi medical college campus Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7505738098 |
| Fax |
|
| Email |
awasya.84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Rathore |
| Designation |
Assistant Professor in department of Anaesthesiology |
| Affiliation |
Gandhi Medical College Bhopal |
| Address |
Operation theatre, 2nd floor, Department of Anaesthesiology, Gandhi medical College, Bhopal
Gandhi medical College campus
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7505738098 |
| Fax |
|
| Email |
drsandeeprathore1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Gandhi Medical College Bhopal 462001 Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [] |
|
|
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 Syed Zeb Raza |
Gandhi Medical College, Bhopal |
Department of Anaesthesiology, Block 1,room no 1
Bhopal
MADHYA PRADESH |
7505738098
sahil.naqvi91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Mallampatti grade I and II |
|
| ExclusionCriteria |
| Details |
Mallampatti grade III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the intubation characteristics of video larynngoscope and mcCoy laryngocope in patients undergoing general anesthesia |
Hemodynamic parameters will be assessed till 20 minutes at time interval of 0,1,2,3,5,10,15 and 20 minutes post successful intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess number of attempts, hemodynamic parameters & adverse effects if any while using both laryngoscope |
Hemodynamic parameters will be assessed till 20 minutes at time interval of 0,1,2,3,5,10,15 & 20 minutes post successful intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
23/02/2025 |
| 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="4"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In general anesthesia endotracheal intubation is commonly associated with prolong laryngoscopy and failure Videolaryngoscope has light souce and digital camera at tip of layngoscope that allows visualization of larynx and vocal cord while performing intubation and considered as the latest type Another type of laryngocope is McCoy blade,it has McIntosh blade with a lever controlled hinged tip that provides relatively better glottic visualization,in our study we will evaluate the intubation characteristics of both laryngoscope |