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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RB 10-071 FreeO2-Hypox

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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