| CTRI Number |
CTRI/2024/09/073466 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Video vs. Direct Laryngoscopy: Which Works Better for First-Year Residents? |
|
Scientific Title of Study
|
A comparison of video laryngoscopy and direct laryngoscopy for successful intubation by first year residents. |
| 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 Aishwarya Balasubramanian |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospitals, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Lighthouse Hill Road
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
8879625257 |
| Fax |
|
| Email |
aishwaryab15@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil B V |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College and Hospitals, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Lighthouse Hill Road
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil B V |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College and Hospitals, Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Lighthouse Hill Road
Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Dakshina Kannada, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Balasubramanian |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Lighthouse Hill Road
Mangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 Aishwarya Balasubramanian |
Kasturba Medical College and Hospitals Mangalore |
Department of Anaesthesiology
Kasturba Medical College
Lighthouse Hill Road
Mangalore
Dakshina Kannada
KARNATAKA |
8879625257
aishwaryab15@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
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 |
| Comparator Agent |
Type of intubation done |
Comparison of intubation by videolaryngoscope versus direct laryngoscope by first year residents |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Residents who are in their first three months of their anaesthesiology residency. |
|
| ExclusionCriteria |
| Details |
Residents who have finished their first year of residency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time required to intubate
|
Measured in seconds from insertion of the intubating instrument into the mouth until 1 capnographic wave is observed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glottic view seen |
At the end of intubation |
| Presence of endotracheal tube in airway |
At the end of intubation |
| Number of attempts taken to intubate |
At the end of intubation - with each subsequent attempt defined as a re-insertion of the laryngoscope blade |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2024 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of the study is to assess the superiority of videolaryngoscopy versus direct laryngoscopy for successful intubation by first year residents. The parameters on which this will be determined is the time taken to intubate, the glottic view seen, the success rate of the intubation, the attempts taken to intubate, and the overall satisfaction score of the resident intubating. |