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Automatic Administration of Oxygen During Respiratory Distress

NCT02027181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2014-10-31

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome
  • Hypoxemia

Interventions

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...).

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Erwan L'HER · University Hospital, Brest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02027181 on ClinicalTrials.gov