COVID-19 Respiratory Infection, SARS-CoV-2 Acute Respiratory Disease
Conditions
Keywords
non-invasive ventilation, implementation science
Brief 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.
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.
Interventions
DEVICECPAP helmet
helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation
OTHERStandard of care non-helmet based CPAP ventilation
Standard of care ventilation without helmet-based CPAP
Sponsors
Aliko Dangote Foundation
Nigerian Institute of Medical Research
CDC Foundation
New York University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | 1-4 weeks while on admission | mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, \>30 or \<=10/min |
| Pulse Oximetry | 1-4 weeks while on admission | mild \>90; moderate \<=90; severe, \<88 |
| Disposition | 1-4 weeks while on admission | Died; Improved; Intubated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of using CPAP/O2 helmet solution | 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). |
| Adaptability of the strategy for implementing CPAP/O2 helmet solution | 1-4 weeks while on admission | Qualitative description of helmet use adaptations via self-report; Observed adaptation to patient characteristics |
| Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19 | 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). |
Countries
Nigeria
Contacts
Primary ContactAndre Fenton, PhD
Backup ContactOlugbenga Ogedegbe, MD, MPH
Outcome results
None listed