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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04904484

Acronym

iZephyr

Enrollment

Registered

2021-05-27

Start date

2024-06-01

Completion date

2025-10-01

Last updated

2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aerosol Disease, Covid19, Noninvasive Ventilation

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.

Interventions

DEVICEiZephyr hood

Assessment of an aerosol containment device

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

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 contamination

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Contacts

Primary ContactPriscilla Humado

priscilla.humado1@nhs.net02033137306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026