Acute Respiratory Distress Syndrome, Hypoxemia
Conditions
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.
Interventions
DEVICEDevice FreeO2 v2.0
* Automatic adjustment of oxygen through the Free O2 device. * FreeO2 device in mode medical data collecting(SpO2,EtCO2...).
Sponsors
Ministry of Health, France
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures | 3 days max |
| 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 |
| 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 |
| Duration of administration during hospitalization | 28 days max |
| Number of complications related to the administration of oxygen | 28 days max |
| Frequency of use of invasive or noninvasive ventilation during hospitalization. | 28 days max |
Countries
Canada, France
Outcome results
None listed