Automation Oxygen Flow Titration in Spontaneously Breathing Infants

NCT03614507 | Terminated

• 1 other identifier: FreeO2Bronchio (29BRC18.0091)
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 10

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.

Conditions

Bronchiolitis

Keywords

Hypoxemia; Infants; Oxygen therapy; Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days max

Secondary Outcomes (8)

• Number of patients readmited to hospital within 7 days and 30 days following discharge

  30 days max

• Number of patients needing assisted ventilation (invasive or noninvasive )

  30 days max

• Number of patient admitted to the intensive care unit within 3 days following the hospital admission

  30 days max

• Duration of enteral feeding (hours)

  30 days max

• Duration of intravenous hydration (hours)

  30 days max

Study Arms (2)

FreeO2 group

EXPERIMENTAL

Automatic oxygen flow titration

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

Manual group

ACTIVE COMPARATOR

Manual oxygen flow titration

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

Interventions

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

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

FreeO2 group

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

Manual group

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (10)

La-Roche-Sur-Yon, Departmental Hospital Center

La Roche-sur-Yon, France, 85000, France

Location

Limoges, University Hospital

Limoges, France, 87000, France

Location

Lenval, University Hospital

Nice, France, 06200, France

Location

Angers, University Hospital

Angers, 49993, France

Location

Brest, University Hospital

Brest, 29609, France

Location

CHI Créteil

Créteil, 94000, France

Location

GHBS Lorient

Lorient, 56322, France

Location

Marseille, University Hospital

Marseille, 13285, France

Location

Nantes, University Hospital

Nantes, 44093, France

Location

Rennes, university Hospital

Rennes, 35000, France

Location

MeSH Terms

Conditions

Bronchiolitis; Hypoxia

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Michel ROUE, Dr

  CHU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The technology used does not allow blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: October 9, 2018
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)