| CTRI Number |
CTRI/2014/08/004861 [Registered on: 11/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
08/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
USE OF VIDEO TECHNOLOGY FOR SECURING ENDOTRACHEAL TUBE (A TUBE TO HELP PATIENTS BREATHE) IN PATIENTS WITH SUSPECTED CERVICAL SPINE INJURY |
|
Scientific Title of Study
|
Comparison of McCoy Laryngoscope and CMAC videolaryngoscope in simulated cervical spine patients-A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA JAIN |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
department of anaesthesia,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900171 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DIVYA JAIN |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
department of anaesthesia,PGIMER,Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900171 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIVYA JAIN |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
department of anaesthesia,PGIMER,Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900171 |
| Fax |
|
| Email |
jaindivya77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12 chandigarh,INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Divya Jain |
anaesthesia department |
PGIMER,SECTOR 12,Chandigarh
Chandigarh
CHANDIGARH |
09855900171
jaindivya77@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INTUBATION CONDITION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CMAC videolaryngoscope |
intubating condition with CMAC videolaryngoscope |
| Comparator Agent |
McCoy Laryngoscope |
intubating condition with mccoy laryngoscope in cervical spine injury patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) classification I and II, between the age group of 18-60 years presenting for elective surgery requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Patients with hemodynamic or respiratory compromise and anticipated difficult airway having modified Mallampati grading (MPG) of IV or thyromental distance(TMD) < 6 cm were excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation difficulty scale |
after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All the perioperative data with regards to,cormack Lehane grading, time taken for glottic visualization, time taken to negotiate endotracheal tube, total time taken to intubate, number of attempts and the hemodynamic data . |
At intubation and hemodynamic data till 10 mins post 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)
|
17/11/2012 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
CMAC is a type of videolaryngoscope introduced in anaesthesia practice. It has been tried in difficult airway scenarios. Our aim is to compare the efficacy of CMAC Videolaryngoscope with the McCoy laryngoscope in the simulated cervical spine injury patients. This group of patient presents a challenge to the anaesthestist due to difficulties encountered in securing the airway. |