| CTRI Number |
CTRI/2021/02/031052 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
02/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Using barrier box, we intend to see the ease of intubation in Macintosh Vs KVVL laryngoscope] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
comparison of ease and duration of intubation with Macintosh versus King vision video-laryngoscope using COVID-19 barrier box on manikins, so that we can use one of them (according to study outcome showing ease of intubation) for intubation of COVID patients |
|
Scientific Title of Study
|
Comparison of endotracheal intubation with Macintosh versus King vision video-laryngoscope using COVID-19 barrier box on manikins: A randomised crossover study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyabrata Guru |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar, Odisha
Same as address 1
Khordha
ORISSA
751019
India |
| Phone |
9438641011 |
| Fax |
|
| Email |
satyabrataguru25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyabrata Guru |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar, Odisha
Same as address 1
Khordha
ORISSA
751019
India |
| Phone |
9438641011 |
| Fax |
|
| Email |
satyabrataguru25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyabrata Guru |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar, Odisha
Same as address 1
Khordha
ORISSA
751019
India |
| Phone |
9438641011 |
| Fax |
|
| Email |
satyabrataguru25@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Satyabrata Guru |
AIIMS,Bhubaneswar |
Faculty room, Department of Trauma and Emergency
Khordha
ORISSA |
9438641011
satyabrataguru25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COVID Barrier box |
We intend to see ease and duration of intubation in Macintosh vs KVVL laryngoscope by using COVID barrier box on Manikin |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Faculty members and residents of Anaesthesia and Emergency medicine having intubation experience more than 1 year |
|
| ExclusionCriteria |
| Details |
Faculty members and residents of Anaesthesia and Emergency medicine having intubation experience more than 1 year not willing to take part in the study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required for successful intubation (IT) in seconds measured by an observer |
The outcome ( IT) in seconds will be assessed from base line i.e. 0 seconds to time required for successful intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of Intubation ( Perception of intubation difficulties, no. of attempts of intubation) |
From base line i.e. 0 seconds, when intubation starts to completion of successful intubation |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2021 |
| Date of Study Completion (India) |
25/08/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management plays an essential role in both anaesthesia practice and emergency medicine. In the present COVID-19 pandemic various barriers are suggested during aerosol generating procedures (AGPs). COVID-19 barrier box is one such barrier to restrict the spread of aerosol, thus decreasing the risk of transmission of infection to the intubating health care personnel. (1) Although the need for a change in intubation practice, through barriers to reduce the aerosol spread is apparent, but it will not be without a learning curve. Moreover, the ease of intubation using either laryngoscopes through the barrier box could vary. We plan to compare the ease of intubation two types of laryngoscopes in the manikin and hypothesize that both the laryngoscopes are comparable. |