Trials / Terminated
TerminatedNCT04457817
Compensatory Reserve Index (CRI) for Management of COVID-19
CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 16 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label. The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CRI | Monitoring via CRI |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-04-08
- Completion
- 2021-04-08
- First posted
- 2020-07-07
- Last updated
- 2021-11-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04457817. Inclusion in this directory is not an endorsement.