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

Imperial College Healthcare NHS Trust

Status: Not yet enrolling

Conditions: Aerosol Disease; Noninvasive Ventilation; Covid19

Treatments: Device: iZephyr hood

Study type: Interventional

Funder types: Other

Identifiers

NCT04904484

292573

Details and patient eligibility

About

This study is a safety assessment of the iZephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for COVID-19.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

With i-zephyr

Experimental group

Description:

using the hood

Treatment:

Device: iZephyr hood

Without i-zephyr

No Intervention group

Description:

Not using the hood