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CTRI Number  CTRI/2020/11/029233 [Registered on: 19/11/2020] Trial Registered Prospectively
Last Modified On: 18/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Remote audio visual surveillance of the doffing process ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An observation and comparison of the efficacy and relative satisfaction of Health Care Workers while being monitored by the standard BUDDY technique versus the Remote Audio Visual Doffing Surveillance (RADS) of the doffing process during the COVID 19 Pandemic 
Scientific Title of Study   Comparison of the efficacy and relative satisfaction of Remote Audio-visual Doffing Surveillance (RADS) technique versus the standard buddy technique for monitoring the doffing process of health care workers during COVID 19 pandemic : an observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naveen Naik B 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute Of Medical Education And Research 
Address  Department of Anaesthesia and Intensive Care, Fourth Floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh - 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8872377925  
Fax    
Email  navin.amc123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Naveen Naik B 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute Of Medical Education And Research 
Address  Department of Anaesthesia and Intensive Care, Fourth Floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh - 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8872377925  
Fax    
Email  navin.amc123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Naveen Naik B 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute Of Medical Education And Research 
Address  Department of Anaesthesia and Intensive Care, Fourth Floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh - 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8872377925  
Fax    
Email  navin.amc123@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research 
 
Primary Sponsor  
Name  Naveen Naik B 
Address  Department of Anaesthesia and Intensive Care, Fourth Floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Naveen Naik B  Post Graduate Institute of Medical Education and Research   Department of Anaesthesia and Intensive Care, Fourth floor, Nehru hospital, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 		 8872377925

navin.amc123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health Care Workers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Remote Audio visual surveillance technique of monitoring the doffing process   The doffing process of the Health Care Workers will be observed from a console room via a camera installed in the doffing area. A person blinded to the purpose of the study will be monitoring the doffing process. The step at which the breech in the protocol occurs, or where the health worker commits an error and / or is corrected by the monitoring staff will be noted by another silent observer.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Should have undergone training in the donning and doffing process at least once or twice.
2. A member of the staff working at the COVID unit in PGIMER.
 
 
ExclusionCriteria 
Details  1. The HCW who will be doffing for the first time.
2. The HCW doffing due to an emergency (health issue of the HCW, or due to an observed damage in the PPE).
3. Pregnant, breast feeding, history of joint replacements or other prosthetic devices, inflammatory skin conditions or having open wounds.
4. Refuses to participate in the study.
5. HCW who is performing this study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study and compare the incidence of error with regard to the standard CDC doffing guidelines during the doffing process of health care workers while they are being monitored by a buddy and also when they are being monitored using Remote Audio-visual Doffing Surveillance (RADS) monitoring system.  Comparison will be done after completion of all the case observations i.e at the end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the satisfaction of the HCW’s regarding their own safety while they are being monitored by the two techniques.  The comparison of the satisfaction among the two groups will be done at the end of the study. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/12/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  


 

MATERIAL AND METHODS

 

Design: Single center observational study

Study setting: Nehru hospital and Nehru extension block, PGIMER, Chandigarh

Study Participants: Health care workers (HCW’s) in Post Graduate Institute of Medical Education and Research, Chandigarh who were trained in the process of donning and doffing for one or two days.

Study protocol:

The senior and junior residents, nursing officers, health and sanitation attendants will all be included in the study. The participants will be classified into three categories as under:

Category 1: Doctors

Category 2: Nursing staff

Category 3: Health and Sanitation staff

 

 The doffing process of at least 200 HCW’s belonging to all the categories will be observed. This will include 100 HCW’s who will be doffing with the help of an assistant (group Buddy) and 100 other HCW’s who will be doffing under the Remote Audio-visual Doffing Surveillance (group RADS) system.  Both the groups (Buddy and RADS) will be monitored by a third person who will be blinded to the purpose of the study and will note the errors based on the CDC guidelines of doffing process.

 

These HCW’s of both the groups will later be requested to fill a short questionnaire based on Likert scale in order to analyze separately their level of satisfaction regarding multiple factors during the doffing process. Their satisfaction would be analyzed on the basis of safety, communicability, ease and reassurance provided during the doffing process. Suggestions would be taken and also, they would be asked to rate their doffing experience on a scale of 5, in order to compare the two techniques of monitoring.

 

 

Statistical analysis:

This is an observational study and we intend to include volunteers who will be working in the designated COVID / COVID suspect units in the OR/ICU/HDU areas during the study period of three months.

 

Sample size calculation:

 

We are planning a study of independent cases and controls with 1 control(s) per case.  Prior data indicate that the failure rate among controls (buddy system) is 0.40. If the true failure rate for experimental subjects is 0.20 (a 50% change), we will need to study 91 subjects in each group/ technique to be able to reject the null hypothesis that the failure rates for the two techniques are equal with probability (power) 0.80.   The Type I error probability associated with this test of this null hypothesis is 0.05.  We will use a chi-squared statistic or Fisher’s exact test to evaluate this null hypothesis.

Assuming a 10% drop out rate we thus would conduct the study in at least 200 subjects, 100 belonging to each group.

 

 

References:

 

1.         Tomas ME, Kundrapu S, Thota P, et al. Contamination of Health Care Personnel During Removal of Personal Protective Equipment. JAMA Intern Med. 2015;175(12):1904-1910.

2.          Edmond MB, Diekema DJ, Perencevich EN. Ebola virus disease and the need for new personal protective equipment. JAMA. 2014;312(23):2495-2496.

3.          Kang J, O’Donnell JM, Colaianne B, Bircher N, Ren D, Smith KJ. Use of personal protective equipment among health care personnel: Results of clinical observations and simulations. Am J Infect Control. 2017;45(1):17-23.

4.          Osei-Bonsu K, Masroor N, Cooper K, et al. Alternative doffing strategies of personal protective equipment to prevent self-contamination in the health care setting. Am J Infect Control. 2019;47(5):534-539.

 

 


 

PROFORMA

 

 

Serial number:

 

Group: RADS / BUDDY TECHNIQUE                                          

Name:                                    

Age:         

Sex:       

Phone no:  

Designation:  

Duty shift:

Area of posting:

Reason for doffing: REGULAR / EMERGENCY

Category of the HCW:

 

S.num

Step

 

Correctly done

Error made

1.      

Engage trained observer

 

 

2.      

Inspect

 

 

 

3.      

Disinfect outer gloves

 

 

4.      

Remove apron

 

 

5.      

Inspect

 

 

 

6.      

Disinfect and remove outer gloves

 

 

7.      

Inspect and disinfect inner gloves

 

 

8.      

Remove face shield

 

 

9.      

Disinfect inner gloves

 

 

10.   

Remove surgical hood

 

 

11.   

Disinfect inner gloves

 

 

12.   

Remove coverall

 

 

13.   

Disinfect inner gloves

 

 

14.   

Remove boot covers

 

 

15.   

Disinfect and change inner gloves

 

 

16.   

Remove N95 respirator

 

 

17.   

Disinfect inner gloves

 

 

18.   

Disinfect washable shoes

 

 

19.   

Disinfect and remove inner gloves

 

 

 

20.   

Perform hand hygiene

 

 

21.   

Inspect

 

 

 

Total number of errors made:

 

 

 

 

 

Questionnaire for the HCW

 

How was your experience during the doffing process with regard to:

                                                

 

 

Very bad

1/5

Bad

2/5

Average

3/5

Good

4/5

Very Good

5/5

Your anxiety

 

 

 

 

 

The quality of monitoring during the doffing process

 

 

 

 

 

Your satisfaction regarding the doffing experience

 

 

 

 

 

Overall rating of the safety you felt

 

 

 

 

 

 

 

Suggestions for improvement:

 

 

 
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