Acute Respiratory Distress SyndromePhase 1FreeO2-HypoxNCT02027181
Automatic Administration of Oxygen During Respiratory Distress
A Phase 1 study testing Device FreeO2 v2.0 in people with Acute Respiratory Distress Syndrome and Hypoxemia, run by University Hospital, Brest at 4 sites in 2 countries.
Trial summary
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Hypoxemia
- What is being tested?
- Device FreeO2 v2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2011to Oct 2014
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the emergency for respiratory disease (or cardiac - acute pulmonary edema)justifying an oxygen administration to over 3 L / min to maintain a SpO2 ≥ 92%.
- Inclusion within a time less than two hours after the start of the oxygen at the emergency.
- Patient consent,or a close.
Who cannot join
- Necessity of an oxygen flow exceeds 15 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
- Serious ventricular rhythm disorders
- Hemodynamic instability (SBP <80mmHg or recourse to vasopressors)
- Cardiac or respiratory arrest
Show all 12Show fewer
- pH < 7.35 and PaCO2 > 55 mm Hg
- Necessity of a urgent surgery, or coronary revascularization
- Age <18 years
- Pregnant women, lactating
- Patient not relevant
- Unavailability of the prototype FreeO2
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada2 sites
Hopital Hotel Dieux de Levis
Lévis, Quebec
Institut universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec
France2 sites
HIA Clermont Tonnerre
Brest, 29200
Brest, University Hospital
Brest
About this study
Official title: Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.
Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.
- Conditions
- Acute Respiratory Distress Syndrome, Hypoxemia
- Being tested
- Device FreeO2 v2.0
- Medical subject headings
- Respiratory Distress Syndrome, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device FreeO2 v2.0Device
- Automatic adjustment of oxygen through the "Free O2" device.
- "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
Device FreeO2 v2.0Device
- Manual adjustment of oxygen without the assistance of the "FreeO2" device.
- Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
| Study group | Role | What they receive |
|---|---|---|
| device FreeO2 | Experimental | Automatic adjustment of oxygen Receives: Device: Device FreeO2 v2.0 |
| Manual oxygenation | Active comparator | Manual adjustment of oxygen Receives: Device: Device FreeO2 v2.0 |
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 = 92-96% The "acute phase of treatment" is defined by the 3 first hours of treatment by oxygenation and/or until one hour after the end of this last.
Measured: 3 hours or 1 hour after after cessation of oxygenation
Secondary outcomes (7)
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Measured: 3 days max
Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).
Measured: 3 hours or 1 hour after after cessation of oxygenation
Maintaining EtCO2 in a selected area
Measured: 3 hours or 1 hour after after cessation of oxygenation
Oxygen consumption measured at the end of administration
Measured: 3 hours or 1 hour after after cessation of oxygenation
Duration of administration during hospitalization
Measured: 28 days max
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 posted6 Jan 2014 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionOct 2014
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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Erwan L'HER, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027181
- Sponsor's protocol ID
- RB 10-071 FreeO2-Hypox
- Acronym
- FreeO2-Hypox
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2013
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.
PubMed 28729473
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT02027181
- Acronym / sponsor ID
- FreeO2-Hypox / RB 10-071 FreeO2-Hypox
- Conditions
- Acute Respiratory Distress Syndrome, Hypoxemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Jan 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.
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.
Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| device FreeO2 | Experimental | Device: Device FreeO2 v2.0Automatic adjustment of oxygen |
| Manual oxygenation | Active comparator | Device: Device FreeO2 v2.0Manual adjustment of oxygen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to the emergency for respiratory disease (or cardiac - acute pulmonary edema)justifying an oxygen administration to over 3 L / min to maintain a SpO2 ≥ 92%.
- Inclusion within a time less than two hours after the start of the oxygen at the emergency.
- Patient consent,or a close.
Key exclusion criteria (12 listed)
- Necessity of an oxygen flow exceeds 15 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
- Serious ventricular rhythm disorders
- Hemodynamic instability (SBP <80mmHg or recourse to vasopressors)
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 |
|---|---|---|
| Device FreeO2 v2.0* Automatic adjustment of oxygen through the "Free O2" device. * "FreeO2" device in mode medical data collecting(SpO2,EtCO2...). | Device | device FreeO2 |
| Device FreeO2 v2.0* Manual adjustment of oxygen without the assistance of the "FreeO2" device. * Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...). | Device | Manual oxygenation |
Primary outcome
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
Time frame: 3 hours or 1 hour after after cessation of oxygenation
The target zone of oxygen saturation is : SpO2 = 92-96% The "acute phase of treatment" is defined by the 3 first hours of treatment by oxygenation and/or until one hour after the end of this last.
7 secondary outcomes
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Time frame: 3 days max
Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).
Time frame: 3 hours or 1 hour after after cessation of oxygenation
Maintaining EtCO2 in a selected area
Time frame: 3 hours or 1 hour after after cessation of oxygenation
Oxygen consumption measured at the end of administration
Time frame: 3 hours or 1 hour after after cessation of oxygenation
Duration of administration during hospitalization
Time frame: 28 days max
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 31 Oct 2014.
- Derived from this study: PubMed 28729473L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.
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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.
Erwan L'HER principal investigator
University Hospital, Brest
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Device FreeO2 v2.0 in people with Acute Respiratory Distress Syndrome and Hypoxemia, run by University Hospital, Brest at 4 sites in 2 countries.
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: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 3 hours or 1 hour after 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 NCT02027181, 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 31 Oct 2014.