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

NCT04904484 | Not Yet Recruiting DMC

• 1 other identifier: 292573
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aerosol Disease; Covid19; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

With i-zephyr

EXPERIMENTAL

using the hood

Device: iZephyr hood

Without i-zephyr

NO INTERVENTION

Not using the hood

Interventions

iZephyr hood DEVICE

Assessment of an aerosol containment device

With i-zephyr

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients under the age of 18 years or those lacking capacity

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead
• Mercedes AMG PETRONAS Formula One Team: collaborator
• Imperial College London: collaborator

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Priscilla Humado

CONTACT

02033137306; priscilla.humado1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 27, 2021
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share