Automatic Administration of Oxygen During Respiratory Distress
- Conditions
- Acute Respiratory Distress SyndromeHypoxemia
- Interventions
- Device: Device FreeO2 v2.0
- Registration Number
- NCT02027181
- Lead Sponsor
- University Hospital, Brest
- Brief 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.
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- 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.
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description device FreeO2 Device FreeO2 v2.0 Automatic adjustment of oxygen Manual oxygenation Device FreeO2 v2.0 Manual adjustment of oxygen
- Primary Outcome Measures
Name Time Method Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment 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.
- Secondary Outcome Measures
Name Time Method Frequency of use of invasive or noninvasive ventilation during hospitalization. 28 days max nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures 3 days max Maintaining EtCO2 in a selected area 3 hours or 1 hour after after cessation of oxygenation Oxygen consumption measured at the end of administration 3 hours or 1 hour after after cessation of oxygenation Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%). 3 hours or 1 hour after after cessation of oxygenation Duration of administration during hospitalization 28 days max Number of complications related to the administration of oxygen 28 days max
Trial Locations
- Locations (4)
HIA Clermont Tonnerre
🇫🇷Brest, France
Brest, University Hospital
🇫🇷Brest, France
Institut universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦Quebec, Canada
Hopital Hotel Dieux de Levis
🇨🇦Levis, Quebec, Canada