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NCT04904484 Clinical Trial

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

Covid19 Clinical Trial

— iZephyr  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04904484
Other study ID # 292573
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date October 1, 2025

Study information
Verified date March 2024
Source Imperial College Healthcare NHS Trust
Contact Priscilla Humado
Phone 02033137306
Email priscilla.humado1@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date October 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iZephyr hood
Assessment of an aerosol containment device

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Imperial College Healthcare NHS Trust Imperial College London, Mercedes AMG PETRONAS Formula One Team

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 month
Primary 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. 12 months
Primary 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. 12 months
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