Hypoxemic Acute Respiratory DistressInfant-Free02NCT02302183
Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)
A study testing FreeO2 v2.0 automatic adjustment and FreeO2 v2.0 data collecting in people with Hypoxemic Acute Respiratory Distress and Infant Between 1 Month and 24 Months Old, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Hypoxemic Acute Respiratory Distress, Infant Between 1 Month and 24 Months Old, Child Between 2 and 15 Years Old
- What is being tested?
- FreeO2 v2.0 automatic adjustment and FreeO2 v2.0 data collecting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2014to 23 Feb 2017
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to the emergency for respiratory disease justifying an oxygen administration to maintain a SpO2 ≥ 92%.
- inclusion within a time less than 24 hours after the start of the oxygen at the emergency department.
- written consent of the parents of the child
Who cannot join
- Necessity of an oxygen flow exceeds 4 L / min to maintain a SpO2 higher than 92%
- Criteria of gravity justifying immediately a different technique of ventilatory support:
- Disturbance of consciousness with a Glasgow Coma Score ≤ 12
- Hemodynamic instability (MBP < - 2 DS or need for vasopressors)
- Cardiac or respiratory arrest
- pH < 7.35 and PaCO2 > 55 mm Hg
Show all 9Show fewer
- Necessity of a urgent surgery
- Age < 1 month
- Respiratory rate > 80 b/min (1 month-2 years old), > 40 b/min (2 - 10 years old) > 30b/min (> 10 years old) ou < 10 b/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.
In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.
- Conditions
- Hypoxemic Acute Respiratory Distress, Infant Between 1 Month and 24 Months Old, Child Between 2 and 15 Years Old
- Being tested
- FreeO2 v2.0 automatic adjustment, FreeO2 v2.0 data collecting
- Keywords
- Hypoxemic, Respiratory distress, infant
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeO2 v2.0 automatic adjustmentDevice
Also called Automatic adjustment of oxygen through the "Free O2" device., "FreeO2" device in mode medical data collecting(SpO2).
FreeO2 v2.0 data collectingDevice
Also called Manual adjustment of oxygen without the assistance of the "FreeO2" device., Only "FreeO2" device in mode medical data collecting(SpO2)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: device FreeO. | Experimental | Automatic adjustment of oxygen Receives: Device: FreeO2 v2.0 automatic adjustment |
| Manual oxygenation | Active comparator | Manual adjustment of oxygen Receives: Device: FreeO2 v2.0 data collecting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
The target zone of oxygen saturation is : SpO2 = 92-98% The "acute phase of treatment" is defined by the 6 first hours of treatment by oxygenation and/or until one hour after the end of this last.
Measured: 6 hours or 1 hour after cessation of oxygenation
Secondary outcomes (5)
Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).
Measured: 6 hours or 1 hour after after cessation of oxygenation
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Measured: 6 hours or 1 hour after oxygenation cessation
Oxygen consumption measured at the end of administration
Measured: 6 hours or 1 hour after cessation of the oxygenation
Number of complications related to the administration of oxygen
Measured: 28 days max
Frequency of use of invasive or noninvasive ventilation during hospitalization
Measured: 28 days max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study start24 Dec 2014
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxemic Acute Respiratory DistressStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302183
- Sponsor's protocol ID
- Infant-FreeO2
- Acronym
- Infant-Free02
- Status last verified
- Mar 2017
- First submitted
- 24 Nov 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roue JM, Delpeut J, d'Hennezel A, Tierrie T, Barzic A, L'Her E, Cros P. Automatic oxygen flow titration in spontaneously breathing children: An open-label randomized controlled pilot study. Pediatr Pulmonol. 2020 Nov;55(11):3180-3188. doi: 10.1002/ppul.25035. Epub 2020 Aug 31.
PubMed 32827344
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children
- ClinicalTrials.gov ID
- NCT02302183
- Acronym / sponsor ID
- Infant-Free02 / Infant-FreeO2
- Conditions
- Hypoxemic Acute Respiratory Distress, Infant Between 1 Month and 24 Months Old, Child Between 2 and 15 Years Old
- Keywords
- Hypoxemic, Respiratory distress, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 24 Dec 2014 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 26 Nov 2014 (estimated)
- 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 aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.
In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: device FreeO. | Experimental | Device: FreeO2 v2.0 automatic adjustmentAutomatic adjustment of oxygen |
| Manual oxygenation | Active comparator | Device: FreeO2 v2.0 data collectingManual adjustment of oxygen |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Admission to the emergency for respiratory disease justifying an oxygen administration to maintain a SpO2 ≥ 92%.
- inclusion within a time less than 24 hours after the start of the oxygen at the emergency department.
- written consent of the parents of the child
Key exclusion criteria (9 listed)
- Necessity of an oxygen flow exceeds 4 L / min to maintain a SpO2 higher than 92%
- Criteria of gravity justifying immediately a different technique of ventilatory support:
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 v2.0 automatic adjustmentAlso: Automatic adjustment of oxygen through the "Free O2" device., "FreeO2" device in mode medical data collecting(SpO2). | Device | Experimental: device FreeO. |
| FreeO2 v2.0 data collectingAlso: Manual adjustment of oxygen without the assistance of the "FreeO2" device., Only "FreeO2" device in mode medical data collecting(SpO2) | Device | Manual oxygenation |
Primary outcome
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
Time frame: 6 hours or 1 hour after cessation of oxygenation
The target zone of oxygen saturation is : SpO2 = 92-98% The "acute phase of treatment" is defined by the 6 first hours of treatment by oxygenation and/or until one hour after the end of this last.
5 secondary outcomes
Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).
Time frame: 6 hours or 1 hour after after cessation of oxygenation
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Time frame: 6 hours or 1 hour after oxygenation cessation
Oxygen consumption measured at the end of administration
Time frame: 6 hours or 1 hour after cessation of the oxygenation
Number of complications related to the administration of oxygen
Time frame: 28 days max
Frequency of use of invasive or noninvasive ventilation during hospitalization
Time frame: 28 days max
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 32827344Roue JM, Delpeut J, d'Hennezel A, Tierrie T, Barzic A, L'Her E, Cros P. Automatic oxygen flow titration in spontaneously breathing children: An open-label randomized controlled pilot study. Pediatr Pulmonol. 2020 Nov;55(11):3180-3188. doi: 10.1002/ppul.25035. Epub 2020 Aug 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeO2 v2.0 automatic adjustment and FreeO2 v2.0 data collecting in people with Hypoxemic Acute Respiratory Distress and Infant Between 1 Month and 24 Months Old, run by University Hospital, Brest at 1 site 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 9 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: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment (time frame: 6 hours or 1 hour after cessation of oxygenation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302183, which also lists 1 linked publication.
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 3 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.