Automation Oxygen Flow Titration in Spontaneously Breathing Infants

Bronchiolitis Clinical Trial

Official title:

Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03614507
• Other study ID #: FreeO2Bronchio (29BRC18.0091)
• Status: Terminated
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: July 5, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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)

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Device:
• 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
• 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.

Locations

Country	Name	City	State
France	Angers, University Hospital	Angers
France	Brest, University Hospital	Brest
France	CHI Créteil	Créteil
France	La-Roche-Sur-Yon, Departmental Hospital Center	La Roche-sur-Yon
France	Limoges, University Hospital	Limoges
France	GHBS Lorient	Lorient
France	Marseille, University Hospital	Marseille
France	Nantes, University Hospital	Nantes
France	Lenval, University Hospital	Nice
France	Rennes, university Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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