Automatic Administration of Oxygen During Respiratory Distress

Acute Respiratory Distress Syndrome Clinical Trial

— FreeO2-Hypox  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027181
• Other study ID #: RB 10-071 FreeO2-Hypox
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2013
• Last updated: October 30, 2014
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Hypoxemia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Device FreeO2 v2.0
Automatic adjustment of oxygen through the "Free O2" device. "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
• 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...).

Locations

Country	Name	City	State
Canada	Hopital Hotel Dieux de Levis	Levis	Quebec
Canada	Institut universitaire de Cardiologie et de Pneumologie de Québec	Quebec
France	Brest, University Hospital	Brest
France	HIA Clermont Tonnerre	Brest

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures		3 days max	No
Secondary	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	No
Secondary	Maintaining EtCO2 in a selected area		3 hours or 1 hour after after cessation of oxygenation	No
Secondary	Oxygen consumption measured at the end of administration		3 hours or 1 hour after after cessation of oxygenation	No
Secondary	Duration of administration during hospitalization		28 days max	No
Secondary	Number of complications related to the administration of oxygen		28 days max	No
Secondary	Frequency of use of invasive or noninvasive ventilation during hospitalization.		28 days max	No