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

Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome; Hypoxemia
• Intervention / Treatment: Device: Device FreeO2 v2.0; Device: Device FreeO2 v2.0

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Quebec
    • Levis, Quebec, Canada
      • Hopital Hotel Dieux de Levis
• France
  • Brest, France
    • Brest, University Hospital
  • Brest, France, 29200
    • HIA Clermont Tonnerre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: device FreeO2; Automatic adjustment of oxygen	Device: Device FreeO2 v2.0; Automatic adjustment of oxygen through the "Free O2" device.; "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).; Device: 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...).
Active Comparator: Manual oxygenation; Manual adjustment of oxygen	Device: Device FreeO2 v2.0; Automatic adjustment of oxygen through the "Free O2" device.; "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).; Device: 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...).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment	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.	3 hours or 1 hour after after cessation of oxygenation

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Erwan L'HER, University Hospital, Brest

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Lung Injury; Infant, Premature, Diseases; Hypoxia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: RB 10-071 FreeO2-Hypox