Automation Oxygen Flow Titration in Spontaneously Breathing Infants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 156
Summary
- Conditions
- Bronchiolitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a multicenter, prospective, controlled, randomized, open-label study. Patients will be randomized to either the FreeO2 group for automatic oxygen titration or the manual group for oxygen therapy using manual flow titration.Masking: None (Open Label)Masking Description: The technology used does not allow blinding.Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 11 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03614507
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jean-Michel ROUE, Dr CHU de Brest
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