| CTRI Number |
CTRI/2022/07/044114 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare intubator performance and time taken for intubation using two different barrier devices |
|
Scientific Title of Study
|
Comparative evaluation of intubator performance and time taken for intubation in COVID patients using two different barrier devices in emergency operation theatre:A pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Padhee |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical College,Rishikesh |
| Address |
Department of anaesthesiology,AIIMS,Rishikesh ,Virbhadra road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7077608900 |
| Fax |
|
| Email |
alokpadhee26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Additional professor |
| Affiliation |
AIIMS,Rishikesh |
| Address |
Department of anaesthesiology,AIIMS,Rishikesh,Virbhadra road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
yashwant.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Additional professor |
| Affiliation |
AIIMS,Rishikesh |
| Address |
Department of anaesthesiology,AIIMS,Rishikesh,Virbhadra road
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9411789762 |
| Fax |
|
| Email |
yashwant.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,AIIMS RISHIKESH |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Alok padhee |
Emergency Operation Theatre |
Level 3 Trauma building AIIMS RISHIKESH Virbhadra road
Dehradun
UTTARANCHAL |
7077608900
alokpadhee26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS,Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal intubation using googles vs face shield |
To evaluate time taken for intubation using googles vs face shield as a protective barrier |
| Intervention |
none |
none |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Emergency surgical procedures
2.Either sex
3.Any age
4.Experienced anaesthesiologist either consultant or senior resident who will volunteer
5.All procedures where intubation is required for general anesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient having anticipated difficult airway
2.Use of different devices other than Macintosh laryngoscope for intubation
3.Different techniques(fibre optic or retrograde)used for intubation
4.Pregnant,lactating,obese patients(more than 35kg/m2 BMI) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate time taken for intubation using face shield and googles |
Time taken for intubation will be calculated from participant picking up the laryngoscope (T0) to passage of the cuff of Endotracheal tube just beyond vocal cord (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the ease of intubation
2.Success rate of intubation in 1st attempt
3.Number of attempts taken
4.Mortality and morbidity among patients
5.Failure rate of intubation |
From holding the laryngoscope till maximum of 3 attempts of intubation |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/07/2022 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective,observational, outcome assessor pilot study will be conducted in the patients who will require emergency surgical procedures in emergency operation theatres at AIIIMS, Rishikesh .128 participants volunteers will be divided into two groups where intubations performed wearing face shield will constitute group F while wearing goggles will constitute group G.Intubations will be performed with Macintosh laryngoscope with appropriate size blades and Endotracheal tubes,time taken for intubation will be noted.Time taken for intubation will be calculated from starting point to passage of the cuff of Endotracheal tube just beyond vocal cord.Starting point is defined as when participant picks up the laryngoscope .Our primary objective will be to evaluate time taken for intubation with face shield and goggle.Secondary objective will be to evaluate the ease of intubation,success rate of intubation in first attempt, number of attempts taken, failure rate of intubation.We planned this study to evaluate the functional impact on intubation performance due to use of protective facial barrier devices. |