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.
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
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
370
helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation
Standard of care ventilation without helmet-based CPAP
Nigerian Institute of Medical Research
Yaba, Lagos, Nigeria
RECRUITINGFederal Medical Center, Abeokuta
Abeokuta, Nigeria
RECRUITINGAlex Ekwueme Federal University Teaching Hospital
Enugu, Nigeria
Respiratory rate
mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, \>30 or \<=10/min
Time frame: 1-4 weeks while on admission
Pulse Oximetry
mild \>90; moderate \<=90; severe, \<88
Time frame: 1-4 weeks while on admission
Disposition
Died; Improved; Intubated
Time frame: 1-4 weeks while on admission
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).
Time frame: 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
Time frame: 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).
Time frame: 1-4 weeks while on admission
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Enugu State University Teaching Hospital
Enugu, Nigeria
RECRUITINGUniversity College Hospital
Ibadan, Nigeria
RECRUITINGAminu Kano Teaching Hospital
Kano, Nigeria
RECRUITINGFederal Medical Center, Ebute Metta
Lagos, Nigeria
RECRUITINGLagos University Teaching Hospital
Lagos, Nigeria
RECRUITINGDelta State University Teaching Hospital
Oghara, Nigeria
RECRUITING