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

Sponsor

Imperial College Healthcare NHS Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04904484

Collaborator

Mercedes AMG PETRONAS Formula One Team (Other), Imperial College London (Other)

Enrollment

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aerosol Disease Covid19 Noninvasive Ventilation	Device: iZephyr hood	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention 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 contaminationEnvironmental 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)

Primary Purpose:

Prevention

Official Title:

A Safety Assessment of the iZephyr Hood for Non Invasive Ventilation in COVID-19 Patients

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Outcome Measures

Primary Outcome Measures

Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV [3 month]
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 [12 months]
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 [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Imperial College Healthcare NHS Trust
Mercedes AMG PETRONAS Formula One Team
Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Imperial College Healthcare NHS Trust

ClinicalTrials.gov Identifier:

NCT04904484

Other Study ID Numbers:

292573

First Posted:

May 27, 2021

Last Update Posted:

May 27, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 27, 2021