The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Among Patients With COVID-19

Last updated: June 17, 2021
Sponsor: New York University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT04929691
CDC Foundation Award 1085.1
  • Ages 18-80
  • All Genders

Study Summary

The purpose of the CircumVent Project is to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients admitted to a study site with respiratory distress and suspected orconfirmed COVID-19 infection

Exclusion

Exclusion Criteria:

  • Patients who do not meet eligibility criteria

Study Design

Total Participants: 370
Study Start date:
November 13, 2020
Estimated Completion Date:
December 31, 2021

Study Description

Acute respiratory failure, a major cause of death in COVID-19, is managed with high-flow oxygen therapy via invasive mechanical ventilation. In resource-limited settings like Nigeria the shortage of ventilators and oxygen supply make this option challenging. Evidence-based non-invasive alternatives to mechanical ventilation such as the use of continuous positive airway pressure (CPAP) devices exist, but there have been concerns that non-invasive ventilation may expose healthcare workers to infection from aerosolized dispersion of SARS-CoV-2. The investigators propose to evaluate the feasibility, adaptability and acceptability of a CPAP/O2 helmet solution for non-invasive ventilation among patients with COVID-19 and health workers in eight COVID-19 treatment and isolation centers in Nigeria.

The study will occur in 4 stages: 1) Convene a Steering Committee of key stakeholders and recruit implementation sites; 2) Use the integrated Promoting Action on Research Implementation in Health Services (i-PARiHS) framework to guide a needs assessment of treatment centers' capacity to use high-flow oxygen therapy to treat COVID-19 patients, and utilize the findings to develop an implementation strategy for use of CPAP/ O2 helmet solution; 3) Build infrastructure to support training and data monitoring processes and to develop implementation protocols to evaluate the adaptability of the strategy for the use of the CPAP/O2 helmet; and 4) Train health workers, distribute a CPAP/O2 helmet solution for non-invasive ventilation, pilot test the implementation strategy, and assess feasibility of its use and acceptability that includes monitoring altered risk of SARS-CoV-2 infection among healthcare workers.

Connect with a study center

  • Nigerian Institute of Medical Research

    Yaba, Lagos
    Nigeria

    Active - Recruiting

  • Federal Medical Center, Abeokuta

    Abeokuta,
    Nigeria

    Active - Recruiting

  • Alex Ekwueme Federal University Teaching Hospital

    Enugu,
    Nigeria

    Active - Recruiting

  • Enugu State University Teaching Hospital

    Enugu,
    Nigeria

    Active - Recruiting

  • University College Hospital

    Ibadan,
    Nigeria

    Active - Recruiting

  • Aminu Kano Teaching Hospital

    Kano,
    Nigeria

    Active - Recruiting

  • Federal Medical Center, Ebute Metta

    Lagos,
    Nigeria

    Active - Recruiting

  • Lagos University Teaching Hospital

    Lagos,
    Nigeria

    Active - Recruiting

  • Delta State University Teaching Hospital

    Oghara,
    Nigeria

    Active - Recruiting

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