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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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SARS-CoV-2 Acute Respiratory Disease, COVID-19 Respiratory Infection

Intervention / Treatment
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* Device: CPAP helmet
* Other: Standard of care non-helmet based CPAP ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP- Helmet Users<br>Patients admitted to a study site with suspected or confirmed COVID-19 and who consented to using the CPAP helmet | Device: CPAP helmet<br>* helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation<br>|
| Active Comparator: Non-CPAP helmet users<br>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<br>* Standard of care ventilation without helmet-based CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | 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 | mild >90; moderate <=90; severe, <88 | 1-4 weeks while on admission | 
| Disposition | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive ventilation, implementation science