| CTRI Number |
CTRI/2018/08/015428 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
16/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare two laryngoscopes for teaching intubation |
|
Scientific Title of Study
|
Comparison Between Mcgrath And Macintosh Laryngocopes As An Educational Tool For Successful Intubation By Untrained Doctors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Githin George |
| Designation |
PG Resident |
| Affiliation |
MOSC Medical College |
| Address |
Department of Anaesthesia
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
04842885740 |
| Fax |
|
| Email |
githin_7@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sara Vergis |
| Designation |
Professor |
| Affiliation |
MOSC Medical College |
| Address |
Department Anaesthesia
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
04842885740 |
| Fax |
|
| Email |
skorula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sara Vergis |
| Designation |
Professor |
| Affiliation |
MOSC Medical College |
| Address |
Department Anaesthesia
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
04842885740 |
| Fax |
|
| Email |
skorula@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MOSC Medical College |
| Address |
Kolenchery,
Kerala, 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 |
| Sara Vergis |
MOSC Medical College |
Department of Anaesthesia
Ernakulam
KERALA |
9446596066
skorula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MOSC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Macintosh Laryngoscope |
3 attempts at laryngoscopy for successful intubation |
| Intervention |
Mcgrath Videolaryngoscope |
3 attempts at laryngoscopy for successful intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Final Year Medical Students who have not learned how to do endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Medical students with experience in laryngoscopy and intubation with any laryngoscope |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken for a successful intubation
Number of attempts for a succesful intubation
|
2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ease of glottis Visualisation
2. Ease of Intubation |
2 week |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2018 |
| Date of Study Completion (India) |
22/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Planning for publication in reputed international journal.
First author . Dr Githin
Second auhtor Dr Sara Vergis |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is being conducted to compare the performance of the Mcgrath videolaryngoscope with Macintosh laryngoscope to teach untrained doctors to do successful endotracheal intubation in an intubating mannequin. Study design is a randomised controlled crossover study. The final year medical students are taught to do laryngoscopy and endotracheal intubation with Macintosh laryngoscope and Mcgrath videolaryngoscope. They are taught using structured lecture, video demonstration and practice on the intubating mannequin. After 14 days of the training the students are randomised to two groups with computer generated random numbers in sealed opaque envelopes. Group AB will do intubation on the mannequin with Macintosh followed by Mcgrath videolaryngoscope. Group BA will do intubation with Mcgrath Videolaryngoscope followed by Macintosh. They will be assessed for Time taken for succesful intubation and Number of attempts for a successful intubation. Ease of Intubation and Ease of glottis visualisation is measured on the Likert scale. STATISTICAL ANALYSIS · Sample size calculated for 80% power and an alpha error of 5% was 38 in each group · A difference of >10 seconds in intubation time was taken as significant. |