Automatic Administration of Oxygen During Respiratory Distress
NCT ID: NCT02027181
Last Updated: 2014-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
190 participants
INTERVENTIONAL
2011-08-31
2014-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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device FreeO2
Automatic adjustment of oxygen
Device FreeO2 v2.0
* Automatic adjustment of oxygen through the "Free O2" device.
* "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
Manual oxygenation
Manual adjustment of oxygen
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...).
Interventions
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Device FreeO2 v2.0
* Automatic adjustment of oxygen through the "Free O2" device.
* "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
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...).
Eligibility Criteria
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Inclusion Criteria
* Inclusion within a time less than two hours after the start of the oxygen at the emergency.
* Patient consent,or a close.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Erwan L'HER
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Brest
Locations
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Hopital Hotel Dieux de Levis
Lévis, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
HIA Clermont Tonnerre
Brest, , France
Brest, University Hospital
Brest, , France
Countries
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References
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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.
Other Identifiers
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RB 10-071 FreeO2-Hypox
Identifier Type: -
Identifier Source: org_study_id