Trials / Completed
CompletedNCT02074774
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Vapotherm, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IntellO2 | Automated FiO2 regulator that responds to pulse oximetry measures |
| OTHER | Manual control | Standard practice of manually titrating FiO2 as needed. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2017-12-01
- Completion
- 2018-01-01
- First posted
- 2014-02-28
- Last updated
- 2018-06-27
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02074774. Inclusion in this directory is not an endorsement.