Enhanced Hood PPE to Minimize COVID-19 Transmission to Front-line Health Care Workers
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
current IPAC-UHN PPE
modified IPAC-UHN PPE
Sponsored by

About this trial
This is an interventional prevention trial for Covid19 focused on measuring Enhanced PPE, Hood
Eligibility Criteria
Inclusion Criteria:
- Healthy, ASA 1-2 members of intubating team (staff anesthesiologists, fellows, anesthesia assistants, nurses) at the Toronto Western Hospital, University Health Network.
- Age 20-75
- Male or female
Exclusion Criteria:
a. Lack of a donning and doffing PPE training session at TWH in the last 6 months.
Sites / Locations
- Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group C (Control)
Group H (enhanced PPE group )
Arm Description
Will use current IPAC-UHN PPE as described under assigned intervention:
Will use modified IPAC-UHN PPE including the prototype hood as described under assigned intervention:
Outcomes
Primary Outcome Measures
Incidence of contamination of any part of the base clothing or exposed skin of the upper body
Incidence of contamination of any part of the base clothing or exposed skin of the upper body (head or neck, forearms, arms, wrists, hands or torso)
Secondary Outcome Measures
1) Number of body areas contaminated
For the purpose of this outcome, the body will be divided in the following 10 areas: a) face, b) hair or posterior aspect of the head, c) right side of the neck, d) left side of the neck, e) right arm or forearm, f) left arm or forearm, g) left wrist or hand, h) right wrist or hand, i) torso, j) right or left lower extremity.
2) Number of discrete areas of contamination of <1 cm2 and >1 cm2
Number of discrete areas of contamination of <1 cm2 and >1 cm2
3) Visibility during the simulated procedure
Rated by each subject on an 11-point numeric rating scale from 0 (no visibility due to fogging or physical interference of the PPE, leading to inability to perform the required procedures) to 10 (perfect visibility, no fogging or physical interference with required tasks)
4) Ease of intubation procedures when wearing PPE
Assessed using an 11-point numeric rating scale from 0 = extremely difficult PPE made it impossible to intubate, to 10 = Absolutely no obstruction or difficulty added by the PPE
5) Ease of breathing while wearing PPE
Assessed using an 11-point numeric rating scale from 0=felt suffocated, needed to remove the PPE before completing the task to 10 = no difficulty breathing
6) Thermal comfort while wearing the PPE
Reported on an 11-point numeric rating scale from 0 = extremely hot, needed to remove the PPE before completing the tasks to 10= no discomfort due to temperature
7) Incidence of breaching of doffing procedures
Doffing violations will be documented and will be defined as performing a maneuver out of sequence, touching an item of clothing out of sequence, tearing an item of protective clothing, or touching any body part other than an item of protective clothing before performing hand hygiene.
Full Information
NCT ID
NCT04373096
First Posted
April 30, 2020
Last Updated
January 7, 2021
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04373096
Brief Title
Enhanced Hood PPE to Minimize COVID-19 Transmission to Front-line Health Care Workers
Official Title
Development of a Novel Hood Shield to Enhance PPE Security and Minimize COVID-19 Transmission to Front-line Health Care Workers Performing High-risk Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study proposes to compare the effectiveness of two different levels of PPE in protecting front-line health care workers from self-contamination with droplets and aerosolized particles during a simulated endotracheal intubation, an aerosol-generating medical procedure.
Detailed Description
Hospital acquired infection and death of healthcare workers is an alarming problem during the COVID-19 pandemic. Avoiding transmission of COVID-19 to front-line health care workers in Ontario with optimal Protective Personal Equipment (PPE) is a public health priority to prevent attrition of the health care work force at a time when it is most needed to care for the needs of Ontarians.
Health care workers performing Aerosol Generating Medical Procedures (AGMPs) (e.g. endotracheal intubation, bronchoscopy and tracheostomies) are at particularly high risk of infection. During AGMPs, medical personnel are contaminated with virus-loaded micro-droplets that may be suspended in the air for up to 3 hours.
Use of effective PPE is paramount in protecting health care workers during these high-risk procedures. Limited world-wide supplies of PPE and disruption of supply chains is a current concern. Having local sources of PPE production could help secure supply and protect Ontario's health care work force.
Current standard PPE equipment used during high-risk procedures in Ontario includes a fit-tested N95 mask, an open face shield, a procedure gown and double extended-cuff gloves. This level of PPE leaves certain areas of the head and neck exposed to contamination with viral aerosol and droplets, and could be a source for self-contamination despite meticulous donning and doffing. In fact, extensive contamination of the front surfaces, the neck, forearms, wrists and hands has been previously identified during simulation of medical procedures.
Contamination of the upper body, especially the head and neck, hands and wrists poses the highest risk of potential infection as viral contaminants in these parts of the body are most likely to reach the mucosal surfaces of the mouth, nose and eyes, which are the recognized entry points of viral infection.
The investigators propose to design and test a protective hood to be used in place of the open shield to provide enhanced coverage of the upper body during high risk procedures. This hood would be used along an N95 mask, procedure gown and double extended-cuff gloves, allowing for effective barrier protection against SARS-CoV-2 rich droplets and microdroplets by providing the physician with a barrier that covers his/her upper torso from contamination.
In partnership with 2 Ontario companies (MVF & Associates and Piedmont Plastics), the investigatorshave designed a hood to cover the entire upper body from the head down to the elbows. The hood is made of polypropylene spunbond nonwoven fabric, a waterproof, air permeable material and a polycarbonate visor.
The use of a hood could positively impact the safety of airway management and other AGMPs during the pandemic by reducing contamination of the upper body. The proposed study is important because it is the first one to evaluate the potential impact of a hood to enhance PPE. Ultimately, decreased levels of contamination by droplets may effectively reduce the risk of health care worker infection by SARS CoV2 virus after an AGMP such as endotracheal intubation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Enhanced PPE, Hood
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The research coordinator documenting all outcome data will be blinded to the group allocation.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group C (Control)
Arm Type
Active Comparator
Arm Description
Will use current IPAC-UHN PPE as described under assigned intervention:
Arm Title
Group H (enhanced PPE group )
Arm Type
Experimental
Arm Description
Will use modified IPAC-UHN PPE including the prototype hood as described under assigned intervention:
Intervention Type
Device
Intervention Name(s)
current IPAC-UHN PPE
Intervention Description
Fit-tested N95 mask
Open face shield
Double extended-cuff
Intervention Type
Device
Intervention Name(s)
modified IPAC-UHN PPE
Intervention Description
Fit-tested N95 mask
Hood
Double extended-cuff gloves
Primary Outcome Measure Information:
Title
Incidence of contamination of any part of the base clothing or exposed skin of the upper body
Description
Incidence of contamination of any part of the base clothing or exposed skin of the upper body (head or neck, forearms, arms, wrists, hands or torso)
Time Frame
0-1 hour After doffing is complete
Secondary Outcome Measure Information:
Title
1) Number of body areas contaminated
Description
For the purpose of this outcome, the body will be divided in the following 10 areas: a) face, b) hair or posterior aspect of the head, c) right side of the neck, d) left side of the neck, e) right arm or forearm, f) left arm or forearm, g) left wrist or hand, h) right wrist or hand, i) torso, j) right or left lower extremity.
Time Frame
0-1 hour After doffing is complete
Title
2) Number of discrete areas of contamination of <1 cm2 and >1 cm2
Description
Number of discrete areas of contamination of <1 cm2 and >1 cm2
Time Frame
0-1 hour After doffing is complete
Title
3) Visibility during the simulated procedure
Description
Rated by each subject on an 11-point numeric rating scale from 0 (no visibility due to fogging or physical interference of the PPE, leading to inability to perform the required procedures) to 10 (perfect visibility, no fogging or physical interference with required tasks)
Time Frame
0-1 hour After doffing is complete
Title
4) Ease of intubation procedures when wearing PPE
Description
Assessed using an 11-point numeric rating scale from 0 = extremely difficult PPE made it impossible to intubate, to 10 = Absolutely no obstruction or difficulty added by the PPE
Time Frame
0-1 hour After doffing is complete
Title
5) Ease of breathing while wearing PPE
Description
Assessed using an 11-point numeric rating scale from 0=felt suffocated, needed to remove the PPE before completing the task to 10 = no difficulty breathing
Time Frame
0-1 hour After doffing is complete
Title
6) Thermal comfort while wearing the PPE
Description
Reported on an 11-point numeric rating scale from 0 = extremely hot, needed to remove the PPE before completing the tasks to 10= no discomfort due to temperature
Time Frame
0-1 hour After doffing is complete
Title
7) Incidence of breaching of doffing procedures
Description
Doffing violations will be documented and will be defined as performing a maneuver out of sequence, touching an item of clothing out of sequence, tearing an item of protective clothing, or touching any body part other than an item of protective clothing before performing hand hygiene.
Time Frame
0-1 hour After doffing is complete
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, ASA 1-2 members of intubating team (staff anesthesiologists, fellows, anesthesia assistants, nurses) at the Toronto Western Hospital, University Health Network.
Age 20-75
Male or female
Exclusion Criteria:
a. Lack of a donning and doffing PPE training session at TWH in the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongyu Jin
Phone
4166035800
Ext
2016
Email
rongyu.jin@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mehdi Soheili
Phone
4166035800
Ext
2016
Email
mehdi.soheili@uhnresearch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anahi Perlas, MD,FRCPC
Organizational Affiliation
Toronto Western Hospital , UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T-2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongyu (Cindy) Jin
Phone
416603-5800
Ext
2016
Email
rongyu.jin@uhn.ca
First Name & Middle Initial & Last Name & Degree
Mehdi Soheili
Phone
415603-5800
Ext
2016
Email
mehdi.soheili@uhnresearch.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhanced Hood PPE to Minimize COVID-19 Transmission to Front-line Health Care Workers
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