Automation Oxygen Flow Titration in Spontaneously Breathing Infants (FreeO2Bronchio)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Bronchiolitis

Treatments: Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titration; Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titration

Study type: Interventional

Funder types: Other

Identifiers

NCT03614507

FreeO2Bronchio (29BRC18.0091)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

FreeO2 group

Experimental group

Description:

Automatic oxygen flow titration

Treatment:

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

Manual group

Active Comparator group

Description:

Manual oxygen flow titration

Treatment:

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