Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04373096

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

current IPAC-UHN PPE

modified IPAC-UHN PPE

Study Details

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.

Conditions

Covid19

Study ID

NCT04373096

Start date

Dec 7, 2020

Status verified date

Apr, 2020

Completion date

Oct 31, 2021

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group C (Control)

Will use current IPAC-UHN PPE as described under assigned intervention:

experimental: Group H (enhanced PPE group )

Will use modified IPAC-UHN PPE including the prototype hood as described under assigned intervention:

Interventions

current IPAC-UHN PPE

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

modified IPAC-UHN PPE

  • Fit-tested N95 mask
  • Hood
  • Double extended-cuff gloves

Primary outcome measure

  • Incidence of contamination of any part of the base clothing or exposed skin of the upper body [ Time Frame: 0-1 hour After doffing is complete ]

Central Contacts and Locations

Central contacts

Rongyu Jin

4166035800rongyu.jin@uhn.ca

Mehdi Soheili

4166035800mehdi.soheili@uhnresearch.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T-2S8

Contacts

Rongyu (Cindy) Jin

416603-5800rongyu.jin@uhn.ca

Mehdi Soheili

415603-5800mehdi.soheili@uhnresearch.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 11, 2021

Last verified

Apr, 2020

Keywords

  • Enhanced PPE
  • Hood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-01-11.