Trials / Terminated
TerminatedNCT03614507
Automation Oxygen Flow Titration in Spontaneously Breathing Infants
Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- University Hospital, Brest · Academic / Other
- Sex
- All
- Age
- 1 Month – 1 Year
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age. FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.
Detailed description
This is a controlled, randomized, open-label, multicentre trial. Patients will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the "FreeO2" group for automatic oxygen flow titration or in the "manual" group for Oxygen therapy with manual flow titration. The SpO2 will be recorded continuously in both groups of the study using the FreeO2 device throughout the duration of hospitalization; In the group "FreeO2 ", the device will record the data continuously and allow the automation of oxygen titration - in the group "Manual", the device will only be used to monitor SpO2 and heart rate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FreeO2 (modèle FO2-220-00) automatic oxygen flow titration | Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate |
| DEVICE | FreeO2 (modèle FO2-220-00) manual oxygen flow titration | Manual oxygen flow titration performed by the healthcare provider in charge of the patient (nurse, physician). For this group, the FreeO2 device will only monitor and record SpO2 and heart rate. |
Timeline
- Start date
- 2018-10-09
- Primary completion
- 2023-07-05
- Completion
- 2023-07-05
- First posted
- 2018-08-03
- Last updated
- 2024-12-17
Locations
10 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03614507. Inclusion in this directory is not an endorsement.