|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
28 June 2021 |
|
Main ID: |
NCT04929691 |
|
Date of registration:
|
08/06/2021 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Among Patients With COVID-19
CircumVent |
|
Scientific title:
|
The CircumVent Project: A CPAP/O2 Helmet Solution for Non-Invasive Ventilation Using an Implementation Research Framework |
|
Date of first enrolment:
|
November 13, 2020 |
|
Target sample size:
|
370 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04929691 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Nigeria
| | | | | | | |
|
Contacts
|
|
Name:
|
Andre Fenton, PhD |
|
Address:
|
|
|
Telephone:
|
+1-212-992-6573 |
|
Email:
|
afenton@nyu.edu |
|
Affiliation:
|
|
|
|
Name:
|
Babatunde L Salako, MBBS, FRCP |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Nigerian Institute for Medical Research, Lagos, Nigeria |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
COVID-19 Respiratory Infection
|
|
SARS-CoV-2 Acute Respiratory Disease
|
|
Intervention(s)
|
|
Device: CPAP helmet
|
|
Other: Standard of care non-helmet based CPAP ventilation
|
|
Primary Outcome(s)
|
|
Disposition
[Time Frame: 1-4 weeks while on admission]
|
|
Pulse Oximetry
[Time Frame: 1-4 weeks while on admission]
|
|
Respiratory rate
[Time Frame: 1-4 weeks while on admission]
|
|
Secondary Outcome(s)
|
|
Acceptability of CPAP/O2 helmet solution for non-invasive management of COVID-19
[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]
|
|
Feasibility of using CPAP/O2 helmet solution
[Time Frame: 1- 4 weeks while on admission]
|
|
Secondary ID(s)
|
|
CDC Foundation Award 1085.1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|