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Automation Oxygen Flow Titration in Spontaneously Breathing Infants

Primary Purpose

Bronchiolitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FreeO2 (modèle FO2-220-00) automatic oxygen flow titration
FreeO2 (modèle FO2-220-00) manual oxygen flow titration
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Hypoxemia, Infants, Oxygen therapy, Bronchiolitis

Eligibility Criteria

1 Month - 1 Year (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Angers, University Hospital
  • Brest, University Hospital
  • CHI Créteil
  • La-Roche-Sur-Yon, Departmental Hospital Center
  • Limoges, University Hospital
  • GHBS Lorient
  • Marseille, University Hospital
  • Nantes, University Hospital
  • Lenval, University Hospital
  • Rennes, university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FreeO2 group

Manual group

Arm Description

Automatic oxygen flow titration

Manual oxygen flow titration

Outcomes

Primary Outcome Measures

Length of hospital stay in hours since the admission to the emergency room.
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.

Secondary Outcome Measures

Number of patients readmited to hospital within 7 days and 30 days following discharge
Number of patients needing assisted ventilation (invasive or noninvasive )
Number of patient admitted to the intensive care unit within 3 days following the hospital admission
Duration of enteral feeding (hours)
Duration of intravenous hydration (hours)
Number of reported Adverse Events
Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).
Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)

Full Information

First Posted
July 30, 2018
Last Updated
July 28, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03614507
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
OXYNOV discontinues loan of FREEO2 devices
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
July 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Hypoxemia, Infants, Oxygen therapy, Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FreeO2 group
Arm Type
Experimental
Arm Description
Automatic oxygen flow titration
Arm Title
Manual group
Arm Type
Active Comparator
Arm Description
Manual oxygen flow titration
Intervention Type
Device
Intervention Name(s)
FreeO2 (modèle FO2-220-00) automatic oxygen flow titration
Intervention Description
Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate
Intervention Type
Device
Intervention Name(s)
FreeO2 (modèle FO2-220-00) manual oxygen flow titration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital stay in hours since the admission to the emergency room.
Description
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.
Time Frame
30 days max
Secondary Outcome Measure Information:
Title
Number of patients readmited to hospital within 7 days and 30 days following discharge
Time Frame
30 days max
Title
Number of patients needing assisted ventilation (invasive or noninvasive )
Time Frame
30 days max
Title
Number of patient admitted to the intensive care unit within 3 days following the hospital admission
Time Frame
30 days max
Title
Duration of enteral feeding (hours)
Time Frame
30 days max
Title
Duration of intravenous hydration (hours)
Time Frame
30 days max
Title
Number of reported Adverse Events
Time Frame
30 days max
Title
Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).
Time Frame
30 days max
Title
Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)
Time Frame
30 days max

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel ROUE, Dr
Organizational Affiliation
CHU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers, University Hospital
City
Angers
ZIP/Postal Code
49993
Country
France
Facility Name
Brest, University Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHI Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
La-Roche-Sur-Yon, Departmental Hospital Center
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Limoges, University Hospital
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
GHBS Lorient
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Marseille, University Hospital
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Nantes, University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Lenval, University Hospital
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Rennes, university Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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Automation Oxygen Flow Titration in Spontaneously Breathing Infants

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