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

March 11, 2024 updated by: Imperial College Healthcare NHS Trust

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With i-zephyr
using the hood
Device: iZephyr hood
Assessment of an aerosol containment device
No Intervention: Without i-zephyr
Not using the hood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the background concentration of SARS-Co-V2 around COVID patients receiving NIV
Time Frame: 3 month
Air and surface sampling for SARS Co-V2 around COVID patients receiving non invasive ventilation or high flow oxygen therapy.
3 month
Determine the background concentration of SARS-Co-V2 when the iZephyr hood is in use
Time Frame: 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.
12 months
Impact of iZephyr hood on environmental SARS Co-V2 contamination
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Collaborators

Imperial College London
Mercedes AMG PETRONAS Formula One Team

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292573

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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