Automation Oxygen Flow Titration in Spontaneously Breathing Infants

Not Applicable

Terminated

• Conditions: Bronchiolitis
• Interventions: Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titration; Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titration

• Registration Number: NCT03614507
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Study Start: 2018-10-09
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual group	FreeO2 (modèle FO2-220-00) manual oxygen flow titration	Manual oxygen flow titration
FreeO2 group	FreeO2 (modèle FO2-220-00) automatic oxygen flow titration	Automatic oxygen flow titration

Primary Outcome Measures

Name	Time	Method
Length of hospital stay in hours since the admission to the emergency room.	30 days max	The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Brest, University Hospital; 🇫🇷 Brest, France

Angers, University Hospital; 🇫🇷 Angers, France

La-Roche-Sur-Yon, Departmental Hospital Center; 🇫🇷 La Roche-sur-Yon, France

Limoges, University Hospital; 🇫🇷 Limoges, France

CHI Créteil; 🇫🇷 Créteil, France

Marseille, University Hospital; 🇫🇷 Marseille, France

GHBS Lorient; 🇫🇷 Lorient, France

Nantes, University Hospital; 🇫🇷 Nantes, France

Lenval, University Hospital; 🇫🇷 Nice, France

Rennes, university Hospital; 🇫🇷 Rennes, France