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

New York University (NYU)

Status: Unknown

Conditions: COVID-19 Respiratory Infection; SARS-CoV-2 Acute Respiratory Disease

Treatments: Device: CPAP helmet; Other: Standard of care non-helmet based CPAP ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04929691

CDC Foundation Award 1085.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 370 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 2 patient groups

CPAP- Helmet Users

Experimental group

Description:

Patients admitted to a study site with suspected or confirmed COVID-19 and who consented to using the CPAP helmet

Treatment:

Device: CPAP helmet

Non-CPAP helmet users

Active Comparator group

Description:

Patients admitted to a study site with suspected or confirmed COVID-19 but who did not use a CPAP helmet

Treatment:

Other: Standard of care non-helmet based CPAP ventilation