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

Primary Purpose

Acute Respiratory Distress Syndrome, Hypoxemia

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Device FreeO2 v2.0
Device FreeO2 v2.0
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Hotel Dieux de Levis
  • Institut universitaire de Cardiologie et de Pneumologie de Québec
  • HIA Clermont Tonnerre
  • Brest, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

device FreeO2

Manual oxygenation

Arm Description

Automatic adjustment of oxygen

Manual adjustment of oxygen

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).
Maintaining EtCO2 in a selected area
Oxygen consumption measured at the end of administration
Duration of administration during hospitalization
Number of complications related to the administration of oxygen
Frequency of use of invasive or noninvasive ventilation during hospitalization.

Full Information

First Posted
October 17, 2013
Last Updated
October 30, 2014
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02027181
Brief Title
Automatic Administration of Oxygen During Respiratory Distress
Acronym
FreeO2-Hypox
Official Title
Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
device FreeO2
Arm Type
Experimental
Arm Description
Automatic adjustment of oxygen
Arm Title
Manual oxygenation
Arm Type
Active Comparator
Arm Description
Manual adjustment of oxygen
Intervention Type
Device
Intervention Name(s)
Device FreeO2 v2.0
Intervention Description
Automatic adjustment of oxygen through the "Free O2" device. "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
Intervention Type
Device
Intervention Name(s)
Device FreeO2 v2.0
Intervention Description
Manual adjustment of oxygen without the assistance of the "FreeO2" device. Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
Primary Outcome Measure Information:
Title
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment
Description
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.
Time Frame
3 hours or 1 hour after after cessation of oxygenation
Secondary Outcome Measure Information:
Title
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Time Frame
3 days max
Title
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
Title
Maintaining EtCO2 in a selected area
Time Frame
3 hours or 1 hour after after cessation of oxygenation
Title
Oxygen consumption measured at the end of administration
Time Frame
3 hours or 1 hour after after cessation of oxygenation
Title
Duration of administration during hospitalization
Time Frame
28 days max
Title
Number of complications related to the administration of oxygen
Time Frame
28 days max
Title
Frequency of use of invasive or noninvasive ventilation during hospitalization.
Time Frame
28 days max

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwan L'HER
Organizational Affiliation
University Hospital, Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Hotel Dieux de Levis
City
Levis
State/Province
Quebec
Country
Canada
Facility Name
Institut universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
Country
Canada
Facility Name
HIA Clermont Tonnerre
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Brest, University Hospital
City
Brest
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28729473
Citation
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.
Results Reference
derived

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Automatic Administration of Oxygen During Respiratory Distress

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