Automatic Administration of Oxygen During Respiratory Distress (FreeO2-Hypox)

Regional University Hospital Center (CHRU)

Status and phase

Completed

Phase 1

Conditions

Acute Respiratory Distress Syndrome

Hypoxemia

Treatments

Device: Device FreeO2 v2.0

Study type

Interventional

Funder types

Other

Identifiers

NCT02027181

RB 10-071 FreeO2-Hypox

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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