Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04435275

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual Assistant first, then Human Coach

Human Coach first, then Virtual Assistant

Study Details

Brief summary:

The COVID virus is acquired through droplet and micro droplet transmission. Although healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure to the virus and avoid contamination, the assumption that everyone can precisely remember every step is improbable as many of these procedures are quite complex and involve multiple steps in stressful situations. Further the use of a trained safety officer to ensure adherence is not always feasible due to the ever growing demand of healthcare providers. Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to develop a voice enabled virtual assistant to guide healthcare professionals through the exact steps of clinical procedures including the donning and doffing of PPE, intubation and extubation procedures.

Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of the study to evaluate the utility and functionality of this VA device.

A total of 40 healthcare professionals will be recruited to participate in phase 2 of the study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory assistants and operating room nurses will be randomized to receive instructional guidance by the VA on one test occasion and a human coach on another occasion. During this phase of the study, the effectiveness of this VA prototype will be compared with a trained human safety officer / coach in its ability to provide instructional guidance for 4 safety and clinical procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3) intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).

Conditions

COVID-19

Study ID

NCT04435275

Start date

Jan 2, 2021

Status verified date

May, 2020

Completion date

May 1, 2021

Anticipated

Primary completion date

Mar 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Only anesthesia attending staff are allowed in the phase 1 study.
  • Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant and operating room nurse are qualified to take part in phase 2 of this study. However, only anesthesia staff and fellows and anesthesia assistants will participate in the part that involves intubation and extubation.

Exclusion Criteria:

• Unwillingness to enter the study for phase 1 or phase 2.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Donning PPE using VA then doffing PPE using HC

Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing.

active comparator: Donning PPE using HC then doffing PPE using VA

Study subjects will receive HC guidance for donning first, then VA guidance for doffing.

active comparator: Intubation using VA then extubation using HC;

Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure

active comparator: Intubation using HC then extubation using VA

Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure

Interventions

Virtual Assistant first, then Human Coach

Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).

Human Coach first, then Virtual Assistant

instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).

Primary outcome measure

  • performance of healthcare workers [ Time Frame: 0- 30mins during donning ]
  • performance of healthcare workers [ Time Frame: 0- 30mins during doffing ]
  • performance of healthcare workers [ Time Frame: 0- 30mins during intubation ]
  • performance of healthcare workers [ Time Frame: 0- 30mins during extubation ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, ON M5T 2S8

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 8, 2021

Last verified

May, 2020

Keywords

  • PPE adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-01-08.