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Automation Oxygen Flow Titration in Spontaneously Breathing Infants

NCT ID: NCT03614507

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2023-07-05

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Keywords

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Hypoxemia Infants Oxygen therapy Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

The technology used does not allow blinding.

Study Groups

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FreeO2 group

Automatic oxygen flow titration

Group Type EXPERIMENTAL

FreeO2 (modèle FO2-220-00) automatic oxygen flow titration

Intervention Type DEVICE

Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate

Manual group

Manual oxygen flow titration

Group Type ACTIVE_COMPARATOR

FreeO2 (modèle FO2-220-00) manual oxygen flow titration

Intervention Type DEVICE

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.

Interventions

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FreeO2 (modèle FO2-220-00) automatic oxygen flow titration

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

FreeO2 (modèle FO2-220-00) manual oxygen flow titration

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

1 Month

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel ROUE, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

Locations

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La-Roche-Sur-Yon, Departmental Hospital Center

La Roche-sur-Yon, France, France

Site Status

Limoges, University Hospital

Limoges, France, France

Site Status

Lenval, University Hospital

Nice, France, France

Site Status

Angers, University Hospital

Angers, , France

Site Status

Brest, University Hospital

Brest, , France

Site Status

CHI Créteil

Créteil, , France

Site Status

GHBS Lorient

Lorient, , France

Site Status

Marseille, University Hospital

Marseille, , France

Site Status

Nantes, University Hospital

Nantes, , France

Site Status

Rennes, university Hospital

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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FreeO2Bronchio (29BRC18.0091)

Identifier Type: -

Identifier Source: org_study_id