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

Not Applicable

Not yet recruiting

• Conditions: Aerosol Disease; Covid19; Noninvasive Ventilation
• Interventions: Device: iZephyr hood

• Registration Number: NCT04904484
• Lead Sponsor: Imperial College Healthcare NHS Trust

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.

Study Timeline

• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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)

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Exclusion Criteria

Patients under the age of 18 years or those lacking capacity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
With i-zephyr	iZephyr hood	using the hood

Primary Outcome Measures

Name	Time	Method
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.
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.
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.