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

COVID-19 Respiratory Infection Clinical Trial

— CircumVent  

Official title:

The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929691
• Other study ID #: CDC Foundation Award 1085.1
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: New York University
• Contact: Andre Fenton, PhD
• Phone: +1-212-992-6573
• Email: afenton[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Tract Diseases
• Respiratory Tract Infections
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Device:
• CPAP helmet
helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation

Other:
• Standard of care non-helmet based CPAP ventilation
Standard of care ventilation without helmet-based CPAP

Locations

Country	Name	City	State
Nigeria	Federal Medical Center, Abeokuta	Abeokuta
Nigeria	Alex Ekwueme Federal University Teaching Hospital	Enugu
Nigeria	Enugu State University Teaching Hospital	Enugu
Nigeria	University College Hospital	Ibadan
Nigeria	Aminu Kano Teaching Hospital	Kano
Nigeria	Federal Medical Center, Ebute Metta	Lagos
Nigeria	Lagos University Teaching Hospital	Lagos
Nigeria	Delta State University Teaching Hospital	Oghara
Nigeria	Nigerian Institute of Medical Research	Yaba	Lagos

Sponsors (4)

Lead Sponsor	Collaborator
New York University	Aliko Dangote Foundation, CDC Foundation, Nigerian Institute of Medical Research

Country where clinical trial is conducted

Nigeria, 

References & Publications (6)

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. — View 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. Erratum in: Intensive Care Med. 2014 Aug;40(8):1187. — View 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. Review. — View Citation

Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, Guérin 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. — View 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;20:265. doi: 10.1186/s13054-016-1449-4. Review. — View Citation

Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate	mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, >30 or <=10/min	1-4 weeks while on admission
Primary	Pulse Oximetry	mild >90; moderate <=90; severe, <88	1-4 weeks while on admission
Primary	Disposition	Died; Improved; Intubated	1-4 weeks while on admission
Secondary	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).	1- 4 weeks while on admission
Secondary	Adaptability of the strategy for implementing CPAP/O2 helmet solution	Qualitative description of helmet use adaptations via self-report; Observed adaptation to patient characteristics	1-4 weeks while on admission
Secondary	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).	1-4 weeks while on admission

External Links

•   Circumvent Project homepage