Clinical trial NCT03614507: Automation Oxygen Flow Titration in Spontaneously Breathing Infants
Official title: Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Keywords: Hypoxemia
Infants
Oxygen therapy
Bronchiolitis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 105
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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 = 12. 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
* Lack of informed consent from parents
* Premature birth with a gestational age at birth under 36 weeks
* Severe co-morbidities (cystic fibrosis, immune deficiency, congenital heart disease, neuromuscular illness)

Primary outcomes:
measure: Length of hospital stay in hours since the admission to the emergency room.
timeFrame: 30 days max
Secondary outcomes:
measure: Number of patients readmited to hospital within 7 days and 30 days following discharge
timeFrame: 30 days max
measure: Number of patients needing assisted ventilation (invasive or noninvasive )
timeFrame: 30 days max
measure: Number of patient admitted to the intensive care unit within 3 days following the hospital admission
timeFrame: 30 days max
measure: Duration of enteral feeding (hours)
timeFrame: 30 days max
measure: Duration of intravenous hydration (hours)
timeFrame: 30 days max
measure: Number of reported Adverse Events
timeFrame: 30 days max
measure: Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).
timeFrame: 30 days max
measure: Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)
timeFrame: 30 days max
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers, University Hospital
city: Brest
country: France
facility: Brest, University Hospital
city: Créteil
country: France
facility: CHI Créteil
city: La Roche-sur-Yon
country: France
facility: La-Roche-Sur-Yon, Departmental Hospital Center
city: Limoges
country: France
facility: Limoges, University Hospital
city: Lorient
country: France
facility: GHBS Lorient
city: Marseille
country: France
facility: Marseille, University Hospital
city: Nantes
country: France
facility: Nantes, University Hospital
city: Nice
country: France
facility: Lenval, University Hospital
city: Rennes
country: France
facility: Rennes, university Hospital
Study officials:
affiliation: CHU de Brest
name: Jean-Michel ROUE, Dr
role: PRINCIPAL_INVESTIGATOR
References: