Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchiolitis
- Sponsor
- University Hospital, Brest
- Enrollment
- 105
- Locations
- 10
- Primary Endpoint
- Length of hospital stay in hours since the admission to the emergency room.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants from 1 month of age and less than 1 year of age who present a first episode of bronchiolitis and require oxygen therapy
- •Informed consent of parents (written informed consent will be obtained from the patients' parents or legally authorized representatives)
- •Affiliation to the French social security system
Exclusion Criteria
- •Need for oxygen flow higher than 3 L / min to maintain SpO2 greater than 92%
- •Patient with severity criteria according to the 2019 French National Authority for Health (HAS) guidelines and for whom it's indicated to maintain SpO2 above 94%
- •Criteria of severity justifying from the start another technique of assisted ventilation:
- •Polypnea: respiratory rate (FR)\> 80 c / min.
- •Consciousness with glasgow score (GSC) \<or =
- •Hemodynamic instability (mean arterial pressure (MAP) \<- 2 SD for age or use of vasopressors).
- •Cardiac or respiratory arrest.
- •PCO2\> 55 mm Hg and pH \<7.20 when blood gas are performed
- •Need for urgent surgery
- •Contraindication to the FreeO2 device as described in the user manual
Outcomes
Primary Outcomes
Length of hospital stay in hours since the admission to the emergency room.
Time Frame: 30 days max
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.
Secondary Outcomes
- Number of patients readmited to hospital within 7 days and 30 days following discharge(30 days max)
- Duration of enteral feeding (hours)(30 days max)
- Duration of intravenous hydration (hours)(30 days max)
- Number of patient admitted to the intensive care unit within 3 days following the hospital admission(30 days max)
- Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)(30 days max)
- Number of patients needing assisted ventilation (invasive or noninvasive )(30 days max)
- Number of reported Adverse Events(30 days max)
- Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).(30 days max)