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A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients (iZephyr)

Primary Purpose

Aerosol Disease, Covid19, Noninvasive Ventilation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iZephyr hood
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aerosol Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II)

Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III)

Exclusion Criteria:

Patients under the age of 18 years or those lacking capacity

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
    Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy.
    Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
    Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy inside an iZephyr hood.
    Impact of iZephyr hood on environmental SARS Co-V2 contamination
    Determine if there is a change in the concentration of SARS-Co-V2 virus on the surfaces and in the air samples surrounding a COVID-19 positive patient whilst using the iZephyr compared to when not using the iZephyr.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 15, 2021
    Last Updated
    May 25, 2021
    Sponsor
    Imperial College Healthcare NHS Trust
    Collaborators
    Mercedes AMG PETRONAS Formula One Team, Imperial College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04904484
    Brief Title
    A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients
    Acronym
    iZephyr
    Official Title
    A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College Healthcare NHS Trust
    Collaborators
    Mercedes AMG PETRONAS Formula One Team, Imperial College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.
    Detailed Description
    Demonstrate that safety and suitability of the iZephyr Hood in patients receiving non-invasive ventilation (NIV) or high flow oxygen therapy (HFOT). Determine the user acceptability of the iZephyr Hood in patients receiving NIV and HFOT. Determine the reduction in aerosol spread of COVID-19 viral particles when using the Zephyr hood in patients using non-invasive ventilation or high flow oxygen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aerosol Disease, Covid19, Noninvasive Ventilation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Environmental contamination of SARS Co-V2 (air and surface) will be tested around COVID patients receiving Non-invasive ventilation or high flow oxygen therapy before using the iZephyr hood and then with the iZephyr hood in place, to determine if the hood changes the amount of environmental contamination
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    iZephyr hood
    Intervention Description
    Assessment of an aerosol containment device
    Primary Outcome Measure Information:
    Title
    Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
    Description
    Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy.
    Time Frame
    3 month
    Title
    Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
    Description
    Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy inside an iZephyr hood.
    Time Frame
    12 months
    Title
    Impact of iZephyr hood on environmental SARS Co-V2 contamination
    Description
    Determine if there is a change in the concentration of SARS-Co-V2 virus on the surfaces and in the air samples surrounding a COVID-19 positive patient whilst using the iZephyr compared to when not using the iZephyr.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult COVID-19 negative patients who are requiring non-invasive ventilation (phase II) Adult COVID-19 positive patients who are requiring non-invasive ventilation (Phase III) Exclusion Criteria: Patients under the age of 18 years or those lacking capacity
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Priscilla Humado
    Phone
    02033137306
    Email
    priscilla.humado1@nhs.net

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients

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