Clinical trial NCT02027181: Automatic Administration of Oxygen During Respiratory Distress
Official title: Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Respiratory Distress Syndrome
Hypoxemia
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2014-01-06
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
timeFrame: 3 hours or 1 hour after after cessation of oxygenation
Secondary outcomes:
measure: nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
timeFrame: 3 days max
measure: Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).
timeFrame: 3 hours or 1 hour after after cessation of oxygenation
measure: Maintaining EtCO2 in a selected area
timeFrame: 3 hours or 1 hour after after cessation of oxygenation
measure: Oxygen consumption measured at the end of administration
timeFrame: 3 hours or 1 hour after after cessation of oxygenation
measure: Duration of administration during hospitalization
timeFrame: 28 days max
measure: Number of complications related to the administration of oxygen
timeFrame: 28 days max
measure: Frequency of use of invasive or noninvasive ventilation during hospitalization.
timeFrame: 28 days max
Other outcomes:
Locations:
city: Levis
country: Canada
facility: Hopital Hotel Dieux de Levis
state: Quebec
city: Quebec
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Québec
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Brest
country: France
facility: Brest, University Hospital
Study officials:
affiliation: University Hospital, Brest
name: Erwan L'HER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.