Clinical trial NCT04373096: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: Enhanced PPE
Hood
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of contamination of any part of the base clothing or exposed skin of the upper body
timeFrame: 0-1 hour After doffing is complete
Secondary outcomes:
measure: 1) Number of body areas contaminated
timeFrame: 0-1 hour After doffing is complete
measure: 2) Number of discrete areas of contamination of <1 cm2 and >1 cm2
timeFrame: 0-1 hour After doffing is complete
measure: 3) Visibility during the simulated procedure
timeFrame: 0-1 hour After doffing is complete
measure: 4) Ease of intubation procedures when wearing PPE
timeFrame: 0-1 hour After doffing is complete
measure: 5) Ease of breathing while wearing PPE
timeFrame: 0-1 hour After doffing is complete
measure: 6) Thermal comfort while wearing the PPE
timeFrame: 0-1 hour After doffing is complete
measure: 7) Incidence of breaching of doffing procedures
timeFrame: 0-1 hour After doffing is complete
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Toronto Western Hospital , UHN
name: Anahi Perlas, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: