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

Not Applicable

• Conditions: COVID-19 Respiratory Infection; SARS-CoV-2 Acute Respiratory Disease
• Interventions: Device: CPAP helmet; Other: Standard of care non-helmet based CPAP ventilation

• Registration Number: NCT04929691
• Lead Sponsor: New York University

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.

Study Timeline

• Study Start: 2020-11-13
• Status Verified: 2021-06
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP- Helmet Users	CPAP helmet	Patients admitted to a study site with suspected or confirmed COVID-19 and who consented to using the CPAP helmet
Non-CPAP helmet users	Standard of care non-helmet based CPAP ventilation	Patients admitted to a study site with suspected or confirmed COVID-19 but who did not use a CPAP helmet

Primary Outcome Measures

Name	Time	Method
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
Disposition	1-4 weeks while on admission	Died; Improved; Intubated
Pulse Oximetry	1-4 weeks while on admission	mild \>90; moderate \<=90; severe, \<88

Secondary Outcome Measures

Name	Time	Method
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
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).
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).

Trial Locations

Locations (9)

Aminu Kano Teaching Hospital; 🇳🇬 Kano, Nigeria

Lagos University Teaching Hospital; 🇳🇬 Lagos, Nigeria

Delta State University Teaching Hospital; 🇳🇬 Oghara, Nigeria

Nigerian Institute of Medical Research; 🇳🇬 Yaba, Lagos, Nigeria

Federal Medical Center, Ebute Metta; 🇳🇬 Lagos, Nigeria

Enugu State University Teaching Hospital; 🇳🇬 Enugu, Nigeria

Alex Ekwueme Federal University Teaching Hospital; 🇳🇬 Enugu, Nigeria

Federal Medical Center, Abeokuta; 🇳🇬 Abeokuta, Nigeria

University College Hospital; 🇳🇬 Ibadan, Nigeria