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

NCT04929691 | Unknown

• 1 other identifier: CDC Foundation Award 1085.1
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

non-invasive ventilation; implementation science

Outcome Measures

Primary Outcomes (3)

• 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

• Pulse Oximetry

  mild \>90; moderate \<=90; severe, \<88

  1-4 weeks while on admission

• Disposition

  Died; Improved; Intubated

  1-4 weeks while on admission

Secondary Outcomes (3)

• Feasibility of using CPAP/O2 helmet solution

  1- 4 weeks while on admission

• Adaptability of the strategy for implementing CPAP/O2 helmet solution

  1-4 weeks while on admission

• Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19

  1-4 weeks while on admission

Study Arms (2)

CPAP- Helmet Users

EXPERIMENTAL

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

Device: CPAP helmet

Non-CPAP helmet users

ACTIVE COMPARATOR

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

Other: Standard of care non-helmet based CPAP ventilation

Interventions

CPAP helmet DEVICE

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

CPAP- Helmet Users

Standard of care non-helmet based CPAP ventilation OTHER

Standard of care ventilation without helmet-based CPAP

Non-CPAP helmet users

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients admitted to a study site with respiratory distress and suspected or confirmed COVID-19 infection

You may not qualify if:

• Patients who do not meet eligibility criteria

Sponsors & Collaborators

• New York University: lead
• Aliko Dangote Foundation: collaborator
• Nigerian Institute of Medical Research: collaborator
• CDC Foundation: collaborator

Study Sites (9)

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

RECRUITING

Federal Medical Center, Abeokuta

Abeokuta, Nigeria

RECRUITING

Alex Ekwueme Federal University Teaching Hospital

Enugu, Nigeria

RECRUITING

Enugu State University Teaching Hospital

Enugu, Nigeria

RECRUITING

University College Hospital

Ibadan, Nigeria

RECRUITING

Aminu Kano Teaching Hospital

Kano, Nigeria

RECRUITING

Federal Medical Center, Ebute Metta

Lagos, Nigeria

RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria

RECRUITING

Delta State University Teaching Hospital

Oghara, Nigeria

RECRUITING

Related Publications (7)

• 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.

  PMID: 29595563 BACKGROUND

• 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.

  PMID: 27549178 BACKGROUND

• 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.

  PMID: 27179463 BACKGROUND

• 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.

  PMID: 24817030 BACKGROUND

• 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.

  PMID: 28899408 BACKGROUND

• 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.

  PMID: 11066186 BACKGROUND

• 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.

  PMID: 34446110 DERIVED

Study Officials

• Babatunde L Salako, MBBS, FRCP

  Nigerian Institute for Medical Research, Lagos, Nigeria

  STUDY DIRECTOR

Central Study Contacts

Andre Fenton, PhD

CONTACT

+1-212-992-6573; afenton@nyu.edu

Olugbenga Ogedegbe, MD, MPH

CONTACT

+1-646-501-3435; Olugbenga.Ogedegbe@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 8, 2021
• First Posted: June 18, 2021
• Study Start: November 13, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NG (9)