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

June 17, 2021 updated by: New York University

The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

370

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

  • Name: Andre Fenton, PhD
  • Phone Number: +1-212-992-6573
  • Email: afenton@nyu.edu

Study Contact Backup

Study Locations

  • Nigeria
      • Abeokuta, Nigeria
        • Recruiting
        • Federal Medical Center, Abeokuta
        • Contact:
          • Adenike Odewabi, MBBS
      • Enugu, Nigeria
        • Recruiting
        • Alex Ekwueme Federal University Teaching Hospital
        • Contact:
          • Ifeoma Ulasi, MBBS
      • Enugu, Nigeria
        • Recruiting
        • Enugu State University Teaching Hospital
        • Contact:
          • Ifeoma Ulasi, MBBS
      • Ibadan, Nigeria
        • Recruiting
        • University College Hospital
        • Contact:
          • Samuel O Ajayi, MBBS
      • Kano, Nigeria
        • Recruiting
        • Aminu Kano Teaching Hospital
        • Contact:
          • Aliyu Abdu, MBBS, FMCP
        • Contact:
          • Baba M Musa, MBBS, FRCP
      • Lagos, Nigeria
        • Recruiting
        • Federal Medical Center, Ebute Metta
        • Contact:
          • Adedamola Dada, MBBS
      • Lagos, Nigeria
        • Recruiting
        • Lagos University Teaching Hospital
        • Contact:
          • Muyiwa Rotimi, MBBS
      • Oghara, Nigeria
        • Recruiting
        • Delta State University Teaching Hospital
        • Contact:
          • Onome Ogueh, MBBS
    • Lagos
      • Yaba, Lagos, Nigeria
        • Recruiting
        • Nigerian Institute of Medical Research
        • Contact:
        • Principal Investigator:
          • Babatunde L Salako, MBBS, FRCP

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who do not meet eligibility criteria

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP- Helmet Users
Patients admitted to a study site with suspected or confirmed COVID-19 and who consented to using the CPAP helmet
Device: CPAP helmet
helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation
Active Comparator: Non-CPAP helmet users
Patients admitted to a study site with suspected or confirmed COVID-19 but who did not use a CPAP helmet
Other: Standard of care non-helmet based CPAP ventilation
Standard of care ventilation without helmet-based CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate
Time Frame: 1-4 weeks while on admission
mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, >30 or <=10/min
1-4 weeks while on admission
Pulse Oximetry
Time Frame: 1-4 weeks while on admission
mild >90; moderate <=90; severe, <88
1-4 weeks while on admission
Disposition
Time Frame: 1-4 weeks while on admission
Died; Improved; Intubated
1-4 weeks while on admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of using CPAP/O2 helmet solution
Time Frame: 1- 4 weeks while on admission
Feasibility of Intervention Measure (FIM, Weiner et al. 2017), 4-item instrument with a 5-point ordinal scale (1 = minimum, 5 = maximum) that takes < 5 minutes to complete. Higher scores imply better outcome (greater feasibility).
1- 4 weeks while on admission
Adaptability of the strategy for implementing CPAP/O2 helmet solution
Time Frame: 1-4 weeks while on admission
Qualitative description of helmet use adaptations via self-report; Observed adaptation to patient characteristics
1-4 weeks while on admission
Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19
Time Frame: 1-4 weeks while on admission
Acceptability of Intervention Measure (AIM, Weiner et al. 2017), a 4-item instrument with a 5-point ordinal scale (1= minimum, 5 = maximum). Higher scores imply better outcome (greater acceptability).
1-4 weeks while on admission

Collaborators and Investigators

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

Sponsor

New York University

Collaborators

Aliko Dangote Foundation
Nigerian Institute of Medical Research
CDC Foundation

Investigators

  • Study Director: Babatunde L Salako, MBBS, FRCP, Nigerian Institute for Medical Research, Lagos, Nigeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

November 13, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC Foundation Award 1085.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Any study data to be shared will need to conform to Nigeria national data regulations.

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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