SARS-CoV-2 Acute Respiratory DiseaseCircumVentNCT04929691
The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Among Patients With COVID-19
A study testing CPAP helmet in people with SARS-CoV-2 Acute Respiratory Disease and COVID-19 Respiratory Infection, run by New York University at 9 sites in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease, COVID-19 Respiratory Infection
- What is being tested?
- CPAP helmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 9 sitesNigeria
- Study dates
- 13 Nov 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to a study site with respiratory distress and suspected or confirmed COVID-19 infection
Who cannot join
- Patients who do not meet eligibility criteria
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Nigeria9 sites, 9 recruiting
- Recruiting
Federal Medical Center, Abeokuta
Abeokuta
Adenike Odewabi, MBBS
- Recruiting
Alex Ekwueme Federal University Teaching Hospital
Enugu
Ifeoma Ulasi, MBBS
- Recruiting
Enugu State University Teaching Hospital
Enugu
Ifeoma Ulasi, MBBS
- Recruiting
University College Hospital
Ibadan
Samuel O Ajayi, MBBS
- Recruiting
Aminu Kano Teaching Hospital
Kano
Aliyu Abdu, MBBS, FMCP
Baba M Musa, MBBS, FRCP
- Recruiting
Federal Medical Center, Ebute Metta
Lagos
Adedamola Dada, MBBS
- Recruiting
Lagos University Teaching Hospital
Lagos
Muyiwa Rotimi, MBBS
- Recruiting
Delta State University Teaching Hospital
Oghara
Onome Ogueh, MBBS
- Recruiting
Nigerian Institute of Medical Research
Yaba, Lagos
Oliver Ezechi, MBBS, FWACS, +2348033065683, oezechi@nimr.gov.ng
Babatunde L Salako, MBBS, FRCP
About this study
Official title: The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework
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.
Read the 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.
- Being tested
- CPAP helmet, Standard of care non-helmet based CPAP ventilation
- Keywords
- non-invasive ventilation, implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP helmetDevice
helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation
Standard of care non-helmet based CPAP ventilationOther
Standard of care ventilation without helmet-based CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP- Helmet Users | Experimental | Patients admitted to a study site with suspected or confirmed COVID-19 and who consented to using the CPAP helmet Receives: 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 Receives: Other: Standard of care non-helmet based CPAP ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, >30 or <=10/min
Measured: 1-4 weeks while on admission
Pulse Oximetry
mild >90; moderate <=90; severe, <88
Measured: 1-4 weeks while on admission
Disposition
Died; Improved; Intubated
Measured: 1-4 weeks while on admission
Secondary outcomes (3)
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).
Measured: 1- 4 weeks while on admission
Adaptability of the strategy for implementing CPAP/O2 helmet solution
Qualitative description of helmet use adaptations via self-report; Observed adaptation to patient characteristics
Measured: 1-4 weeks while on admission
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).
Measured: 1-4 weeks while on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start13 Nov 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Aliko Dangote Foundation, Nigerian Institute of Medical Research, CDC Foundation
- Responsible party
- Sponsor
- Investigators
- Babatunde L Salako, MBBS, FRCP, Study director, Nigerian Institute for Medical Research, Lagos, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929691
- Sponsor's protocol ID
- CDC Foundation Award 1085.1
- Acronym
- CircumVent
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any study data to be shared will need to conform to Nigeria national data regulations.
Publications
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.
PubMed 29595563Liu 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.
PubMed 27549178Beitler 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.
PubMed 27179463Brambilla 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.
PubMed 24817030Chiumello 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.
PubMed 28899408Delclaux 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.
PubMed 11066186Ahonkhai 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.
PubMed 34446110
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework
- ClinicalTrials.gov ID
- NCT04929691
- Acronym / sponsor ID
- CircumVent / CDC Foundation Award 1085.1
- Keywords
- non-invasive ventilation, implementation science
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Aliko Dangote Foundation, Nigerian Institute of Medical Research, CDC Foundation
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CPAP- Helmet Users | Experimental | Device: CPAP helmetPatients admitted to a study site with suspected or confirmed COVID-19 and who consented to using the CPAP helmet |
| Non-CPAP helmet users | Active comparator | Other: Standard of care non-helmet based CPAP ventilationPatients admitted to a study site with suspected or confirmed COVID-19 but who did not use a CPAP helmet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted to a study site with respiratory distress and suspected or confirmed COVID-19 infection
Key exclusion criteria (1 listed)
- Patients who do not meet eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP helmethelmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation | Device | CPAP- Helmet Users |
| Standard of care non-helmet based CPAP ventilationStandard of care ventilation without helmet-based CPAP | Other | Non-CPAP helmet users |
Primary outcome
Respiratory rate
Time frame: 1-4 weeks while on admission
mild, 11-19/min; moderate, 20-24/min; severe, 25-30/min; very severe, >30 or <=10/min
Pulse Oximetry
Time frame: 1-4 weeks while on admission
mild >90; moderate <=90; severe, <88
Disposition
Time frame: 1-4 weeks while on admission
Died; Improved; Intubated
3 secondary outcomes
Feasibility of using CPAP/O2 helmet solution
Time frame: 1- 4 weeks while on admission
Adaptability of the strategy for implementing CPAP/O2 helmet solution
Time frame: 1-4 weeks while on admission
Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19
Time frame: 1-4 weeks while on admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Background: PubMed 29595563Patel 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.
- Background: PubMed 27549178Liu 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.
- Background: PubMed 27179463Beitler 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.
- Background: PubMed 24817030Brambilla 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.
- Background: PubMed 28899408Chiumello 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.
- Background: PubMed 11066186Delclaux 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.
- Derived from this study: PubMed 34446110Ahonkhai 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.
- Circumvent Project homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Any study data to be shared will need to conform to Nigeria national data regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babatunde L Salako, MBBS, FRCP study director
Nigerian Institute for Medical Research, Lagos, Nigeria
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP helmet in people with SARS-CoV-2 Acute Respiratory Disease and COVID-19 Respiratory Infection, run by New York University at 9 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andre Fenton, PhD (+1-212-992-6573, afenton@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: 1-4 weeks while on admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929691, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.