Automatic Administration of Oxygen During Respiratory Distress (FreeO2-Hypox)
October 30, 2014 updated by: University Hospital, Brest
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
190
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: device FreeO2
Automatic adjustment of oxygen
|
|
|
Active Comparator: Manual oxygenation
Manual adjustment of oxygen
|
|
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
Time Frame: 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.
|
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
Time Frame: 3 days max
|
3 days max
|
|
Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).
Time Frame: 3 hours or 1 hour after after cessation of oxygenation
|
3 hours or 1 hour after after cessation of oxygenation
|
|
Maintaining EtCO2 in a selected area
Time Frame: 3 hours or 1 hour after after cessation of oxygenation
|
3 hours or 1 hour after after cessation of oxygenation
|
|
Oxygen consumption measured at the end of administration
Time Frame: 3 hours or 1 hour after after cessation of oxygenation
|
3 hours or 1 hour after after cessation of oxygenation
|
|
Duration of administration during hospitalization
Time Frame: 28 days max
|
28 days max
|
|
Number of complications related to the administration of oxygen
Time Frame: 28 days max
|
28 days max
|
|
Frequency of use of invasive or noninvasive ventilation during hospitalization.
Time Frame: 28 days max
|
28 days max
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erwan L'HER, University Hospital, Brest
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- RB 10-071 FreeO2-Hypox
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