Covid19NCT04373096
Enhanced Hood PPE to Minimize COVID-19 Transmission to Front-line Health Care Workers
A study testing current IPAC-UHN PPE and modified IPAC-UHN PPE in people with Covid19, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- current IPAC-UHN PPE and modified IPAC-UHN PPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 7 Dec 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of a donning and doffing PPE training session at TWH in the last 6 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T-2S8
Rongyu (Cindy) Jin, 416603-5800 ext. 2016, rongyu.jin@uhn.ca
Mehdi Soheili, 415603-5800 ext. 2016, mehdi.soheili@uhnresearch.ca
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- current IPAC-UHN PPE, modified IPAC-UHN PPE
- Keywords
- Enhanced PPE, Hood
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
current IPAC-UHN PPEDevice
- Fit-tested N95 mask
- Open face shield
- Double extended-cuff
modified IPAC-UHN PPEDevice
- Fit-tested N95 mask
- Hood
- Double extended-cuff gloves
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control) | Active comparator | Will use current IPAC-UHN PPE as described under assigned intervention: Receives: 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: Receives: Device: modified IPAC-UHN PPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-1 hour After doffing is complete
Secondary outcomes (7)
1) Number of body areas contaminated
For the purpose of this outcome, the body will be divided in the following 10 areas: a) face, b) hair or posterior aspect of the head, c) right side of the neck, d) left side of the neck, e) right arm or forearm, f) left arm or forearm, g) left wrist or hand, h) right wrist or hand, i) torso, j) right or left lower extremity.
Measured: 0-1 hour After doffing is complete
2) Number of discrete areas of contamination of <1 cm2 and >1 cm2
Number of discrete areas of contamination of <1 cm2 and >1 cm2
Measured: 0-1 hour After doffing is complete
3) Visibility during the simulated procedure
Rated by each subject on an 11-point numeric rating scale from 0 (no visibility due to fogging or physical interference of the PPE, leading to inability to perform the required procedures) to 10 (perfect visibility, no fogging or physical interference with required tasks)
Measured: 0-1 hour After doffing is complete
4) Ease of intubation procedures when wearing PPE
Assessed using an 11-point numeric rating scale from 0 = extremely difficult PPE made it impossible to intubate, to 10 = Absolutely no obstruction or difficulty added by the PPE
Measured: 0-1 hour After doffing is complete
5) Ease of breathing while wearing PPE
Assessed using an 11-point numeric rating scale from 0=felt suffocated, needed to remove the PPE before completing the task to 10 = no difficulty breathing
Measured: 0-1 hour After doffing is complete
6) Thermal comfort while wearing the PPE
Reported on an 11-point numeric rating scale from 0 = extremely hot, needed to remove the PPE before completing the tasks to 10= no discomfort due to temperature
Measured: 0-1 hour After doffing is complete
7) Incidence of breaching of doffing procedures
Doffing violations will be documented and will be defined as performing a maneuver out of sequence, touching an item of clothing out of sequence, tearing an item of protective clothing, or touching any body part other than an item of protective clothing before performing hand hygiene.
Measured: 0-1 hour After doffing is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start7 Dec 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD,FRCPC, Principal investigator, Toronto Western Hospital , UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373096
- Sponsor's protocol ID
- 20-5448
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37020172
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04373096
- Acronym / sponsor ID
- 20-5448
- Conditions
- Covid19
- Keywords
- Enhanced PPE, Hood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C (Control) | Active comparator | Device: current IPAC-UHN PPEWill use current IPAC-UHN PPE as described under assigned intervention: |
| Group H (enhanced PPE group ) | Experimental | Device: modified IPAC-UHN PPEWill use modified IPAC-UHN PPE including the prototype hood as described under assigned intervention: |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of a donning and doffing PPE training session at TWH in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| current IPAC-UHN PPE* Fit-tested N95 mask * Open face shield * Double extended-cuff | Device | Group C (Control) |
| modified IPAC-UHN PPE* Fit-tested N95 mask * Hood * Double extended-cuff gloves | Device | Group H (enhanced PPE group ) |
Primary outcome
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
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)
7 secondary outcomes
1) Number of body areas contaminated
Time frame: 0-1 hour After doffing is complete
2) Number of discrete areas of contamination of <1 cm2 and >1 cm2
Time frame: 0-1 hour After doffing is complete
3) Visibility during the simulated procedure
Time frame: 0-1 hour After doffing is complete
4) Ease of intubation procedures when wearing PPE
Time frame: 0-1 hour After doffing is complete
5) Ease of breathing while wearing PPE
Time frame: 0-1 hour After doffing is complete
6) Thermal comfort while wearing the PPE
Time frame: 0-1 hour After doffing is complete
7) Incidence of breaching of doffing procedures
Time frame: 0-1 hour After doffing is complete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Derived from this study: PubMed 37020172Munoz-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anahi Perlas, MD,FRCPC principal investigator
Toronto Western Hospital , UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing current IPAC-UHN PPE and modified IPAC-UHN PPE in people with Covid19, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongyu Jin (4166035800 ext. 2016, rongyu.jin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.