Clinical trial NCT04929691: The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Among Patients With COVID-19
Official title: The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2 Acute Respiratory Disease
COVID-19 Respiratory Infection
Keywords: non-invasive ventilation
implementation science
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Aliko Dangote Foundation
name: Nigerian Institute of Medical Research
name: CDC Foundation
First posted: 2021-06-18
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory rate
timeFrame: 1-4 weeks while on admission
measure: Pulse Oximetry
timeFrame: 1-4 weeks while on admission
measure: Disposition
timeFrame: 1-4 weeks while on admission
Secondary outcomes:
measure: Feasibility of using CPAP/O2 helmet solution
timeFrame: 1- 4 weeks while on admission
measure: Adaptability of the strategy for implementing CPAP/O2 helmet solution
timeFrame: 1-4 weeks while on admission
measure: Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19
timeFrame: 1-4 weeks while on admission
Other outcomes:
Locations:
city: Yaba
country: Nigeria
facility: Nigerian Institute of Medical Research
state: Lagos
city: Abeokuta
country: Nigeria
facility: Federal Medical Center, Abeokuta
city: Enugu
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
city: Enugu
country: Nigeria
facility: Enugu State University Teaching Hospital
city: Ibadan
country: Nigeria
facility: University College Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Lagos
country: Nigeria
facility: Federal Medical Center, Ebute Metta
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
city: Oghara
country: Nigeria
facility: Delta State University Teaching Hospital
Study officials:
affiliation: Nigerian Institute for Medical Research, Lagos, Nigeria
name: Babatunde L Salako, MBBS, FRCP
role: STUDY_DIRECTOR
References:
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citation: Liu Q, Gao Y, Chen R, Cheng Z. Noninvasive ventilation with helmet versus control strategy in patients with acute respiratory failure: a systematic review and meta-analysis of controlled studies. Crit Care. 2016 Aug 23;20(1):265. doi: 10.1186/s13054-016-1449-4.
citation: Beitler JR, Owens RL, Malhotra A. Unmasking a Role for Noninvasive Ventilation in Early Acute Respiratory Distress Syndrome. JAMA. 2016 Jun 14;315(22):2401-3. doi: 10.1001/jama.2016.5987. No abstract available.
citation: Brambilla AM, Aliberti S, Prina E, Nicoli F, Del Forno M, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, Tarsia P, Cosentini R. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia. Intensive Care Med. 2014 Jul;40(7):942-9. doi: 10.1007/s00134-014-3325-5. Epub 2014 May 10.
citation: Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0.
citation: Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, Guerin C, Schortgen F, Lefort Y, Antonelli M, Lepage E, Lemaire F, Brochard L. Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: A randomized controlled trial. JAMA. 2000 Nov 8;284(18):2352-60. doi: 10.1001/jama.284.18.2352.
citation: Ahonkhai AA, Musa AZ, Fenton AA, Aliyu MH, Ofotokun I, Hornstein A, Musa BM, Nwosu N, Ulasi I, Ajayi S, Falade C, Dada A, Abdu A, Sunday M, Odewabi A, Rotimi MK, Ogueh O, Steinbach A, Ogedegbe G, Salako BL, Ezechi OC. The CircumVent Project: a CPAP/O2 helmet solution for non-invasive ventilation using an implementation research framework. Implement Sci Commun. 2021 Aug 26;2(1):93. doi: 10.1186/s43058-021-00193-y.