NCT02027181

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

October 17, 2013

Last Update Submit

October 30, 2014

Conditions

Acute Respiratory Distress SyndromeHypoxemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

device FreeO2

EXPERIMENTAL

Automatic adjustment of oxygen

Device: Device FreeO2 v2.0

Manual oxygenation

ACTIVE COMPARATOR

Manual adjustment of oxygen

Device: Device FreeO2 v2.0

Interventions

Device FreeO2 v2.0DEVICE

* Automatic adjustment of oxygen through the "Free O2" device. * "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

device FreeO2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.
  • Patient consent,or a close.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Hotel Dieux de Levis

Lévis, Quebec, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

Location

HIA Clermont Tonnerre

Brest, 29200, France

Location

Brest, University Hospital

Brest, France

Location

Related Publications (1)

  • 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.

    PMID: 28729473DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeHypoxia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erwan L'HER

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

January 6, 2014

Study Start

August 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations

CA(2)FR(2)