BronchiolitisFreeO2BronchioNCT03614507
Automation Oxygen Flow Titration in Spontaneously Breathing Infants
A study testing FreeO2 (modèle FO2-220-00) automatic oxygen flow titration and FreeO2 (modèle FO2-220-00) manual oxygen flow titration in people with Bronchiolitis, run by University Hospital, Brest at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- FreeO2 (modèle FO2-220-00) automatic oxygen flow titration and FreeO2 (modèle FO2-220-00) manual oxygen flow titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 10 sitesFrance
- Study dates
- 9 Oct 2018to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Angers, University Hospital
Angers, 49993
Brest, University Hospital
Brest, 29609
CHI Créteil
Créteil, 94000
La-Roche-Sur-Yon, Departmental Hospital Center
La Roche-sur-Yon, France, 85000
Limoges, University Hospital
Limoges, France, 87000
GHBS Lorient
Lorient, 56322
Marseille, University Hospital
Marseille, 13285
Nantes, University Hospital
Nantes, 44093
Lenval, University Hospital
Nice, France, 06200
Rennes, university Hospital
Rennes, 35000
About this study
Official title: Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis
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.
Read the 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.
- Conditions
- Bronchiolitis
- Being tested
- FreeO2 (modèle FO2-220-00) automatic oxygen flow titration, FreeO2 (modèle FO2-220-00) manual oxygen flow titration
- Keywords
- Hypoxemia, Infants, Oxygen therapy, Bronchiolitis
- Medical subject headings
- Bronchiolitis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeO2 (modèle FO2-220-00) automatic oxygen flow titrationDevice
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 titrationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FreeO2 group | Experimental | Automatic oxygen flow titration Receives: Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titration |
| Manual group | Active comparator | Manual oxygen flow titration Receives: Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days max
Secondary outcomes (8)
Number of patients readmited to hospital within 7 days and 30 days following discharge
Measured: 30 days max
Number of patients needing assisted ventilation (invasive or noninvasive )
Measured: 30 days max
Number of patient admitted to the intensive care unit within 3 days following the hospital admission
Measured: 30 days max
Duration of enteral feeding (hours)
Measured: 30 days max
Duration of intravenous hydration (hours)
Measured: 30 days max
Number of reported Adverse Events
Measured: 30 days max
Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).
Measured: 30 days max
Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)
Measured: 30 days max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start9 Oct 2018
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Why it stopped: OXYNOV discontinues loan of FREEO2 devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel ROUE, Dr, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614507
- Sponsor's protocol ID
- FreeO2Bronchio (29BRC18.0091)
- Acronym
- FreeO2Bronchio
- Status last verified
- Dec 2024
- First submitted
- 30 Jul 2018
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis
- ClinicalTrials.gov ID
- NCT03614507
- Acronym / sponsor ID
- FreeO2Bronchio / FreeO2Bronchio (29BRC18.0091)
- Conditions
- Bronchiolitis
- Keywords
- Hypoxemia, Infants, Oxygen therapy, Bronchiolitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: OXYNOV discontinues loan of FREEO2 devices
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| FreeO2 group | Experimental | Device: FreeO2 (modèle FO2-220-00) automatic oxygen flow titrationAutomatic oxygen flow titration |
| Manual group | Active comparator | Device: FreeO2 (modèle FO2-220-00) manual oxygen flow titrationManual oxygen flow titration |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
- Need for urgent surgery
- Contraindication to the FreeO2 device as described in the user manual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeO2 (modèle FO2-220-00) automatic oxygen flow titrationAutomatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate | Device | FreeO2 group |
| FreeO2 (modèle FO2-220-00) manual oxygen flow titrationManual 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. | Device | Manual group |
Primary outcome
Length of hospital stay in hours since the admission to the emergency room.
Time frame: 30 days max
The length of hospital stay in hours since admission in the emergency room will be compared between the two groups.
8 secondary outcomes
Number of patients readmited to hospital within 7 days and 30 days following discharge
Time frame: 30 days max
Number of patients needing assisted ventilation (invasive or noninvasive )
Time frame: 30 days max
Number of patient admitted to the intensive care unit within 3 days following the hospital admission
Time frame: 30 days max
Duration of enteral feeding (hours)
Time frame: 30 days max
Duration of intravenous hydration (hours)
Time frame: 30 days max
Number of reported Adverse Events
Time frame: 30 days max
Time spent in the a area of severe desaturation (SpO2 <92%) and of hyperoxia area (SpO2> 98%).
Time frame: 30 days max
Number of patients needing Heated Humidified High Flow Nasal Cannula (HFNNC)
Time frame: 30 days max
Results and safety
The study was stopped early (reason given: OXYNOV discontinues loan of FREEO2 devices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel ROUE, Dr principal investigator
CHU de Brest
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeO2 (modèle FO2-220-00) automatic oxygen flow titration and FreeO2 (modèle FO2-220-00) manual oxygen flow titration in people with Bronchiolitis, run by University Hospital, Brest at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: OXYNOV discontinues loan of FREEO2 devices). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay in hours since the admission to the emergency room. (time frame: 30 days max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.