NCT04373096

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

December 7, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

January 11, 2021

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 30, 2020

Last Update Submit

January 7, 2021

Conditions

Covid19

Keywords

Enhanced PPEHood

Outcome Measures

Primary Outcomes (1)

  • 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)

    0-1 hour After doffing is complete

Secondary Outcomes (7)

  • 1) Number of body areas contaminated

    0-1 hour After doffing is complete

  • 2) Number of discrete areas of contamination of <1 cm2 and >1 cm2

    0-1 hour After doffing is complete

  • 3) Visibility during the simulated procedure

    0-1 hour After doffing is complete

  • 4) Ease of intubation procedures when wearing PPE

    0-1 hour After doffing is complete

  • 5) Ease of breathing while wearing PPE

    0-1 hour After doffing is complete

  • +2 more secondary outcomes

Study Arms (2)

Group C (Control)

ACTIVE COMPARATOR

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

Device: current IPAC-UHN PPE

Group H (enhanced PPE group )

EXPERIMENTAL

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

Device: modified IPAC-UHN PPE

Interventions

current IPAC-UHN PPEDEVICE

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

Group C (Control)
modified IPAC-UHN PPEDEVICE

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

Group H (enhanced PPE group )

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T-2S8, Canada

RECRUITING

Related Publications (1)

  • Munoz-Leyva F, Perlas A, Chin KJ, Soheili M, Li Q, Huszti E, Chan V. A hood shield reduces postdoffing contamination during simulated COVID-19 airway management: an exploratory, simulation-based randomized study. Can J Anaesth. 2023 May;70(5):869-877. doi: 10.1007/s12630-023-02400-x. Epub 2023 Apr 5.

    PMID: 37020172DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anahi Perlas, MD,FRCPC

    Toronto Western Hospital , UHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu Jin

CONTACT

4166035800rongyu.jin@uhn.ca

Mehdi Soheili

CONTACT

4166035800mehdi.soheili@uhnresearch.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The research coordinator documenting all outcome data will be blinded to the group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

December 7, 2020

Primary Completion

August 31, 2021

Study Completion

October 31, 2021

Last Updated

January 11, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)