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
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.

Unknown status
COVID19

Device: current IPAC-UHN PPE

Fit-tested N95 mask
Open face shield
Double extended-cuff

Device: modified IPAC-UHN PPE

Fit-tested N95 mask
Hood
Double extended-cuff gloves

Eligibility Criteria

Inclusion Criteria:

1. Healthy, ASA 1-2 members of intubating team (staff anesthesiologists, fellows,
anesthesia assistants, nurses) at the Toronto Western Hospital, University Health
Network.

2. Age 20-75

3. Male or female

Exclusion Criteria:

a. Lack of a donning and doffing PPE training session at TWH in the last 6 months.

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 75 Years
Countries
Canada
Locations

Toronto Western Hospital
Toronto, Ontario, Canada

Investigator: Rongyu (Cindy) Jin
Contact: 416603-5800
rongyu.jin@uhn.ca

Contacts

Rongyu Jin
4166035800 - 2016
rongyu.jin@uhn.ca

Mehdi Soheili
4166035800 - 2016
mehdi.soheili@uhnresearch.ca

Anahi Perlas, MD,FRCPC, Principal Investigator
Toronto Western Hospital , UHN

University Health Network, Toronto
NCT Number
Keywords
Enhanced PPE
Hood
MeSH Terms
COVID-19