Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2) (Infant-Free02)

March 2, 2017 updated by: University Hospital, Brest

Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children

The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.

In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • France
      • Brest, France, 29609
        • CHRU de Brest

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

1 month to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to the emergency for respiratory disease justifying an oxygen administration to maintain a SpO2 ≥ 92%.
  • inclusion within a time less than 24 hours after the start of the oxygen at the emergency department.
  • written consent of the parents of the child

Exclusion Criteria:

  • Necessity of an oxygen flow exceeds 4 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
    • Hemodynamic instability (MBP < - 2 DS or need for vasopressors)
    • Cardiac or respiratory arrest
    • pH < 7.35 and PaCO2 > 55 mm Hg
    • Necessity of a urgent surgery
    • Age < 1 month
    • Respiratory rate > 80 b/min (1 month-2 years old), > 40 b/min (2 - 10 years old) > 30b/min (> 10 years old) ou < 10 b/min

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
Active Comparator: Manual oxygenation
Manual adjustment of oxygen
Device: FreeO2 v2.0 data collecting
Other Names:
  • Manual adjustment of oxygen without the assistance of the "FreeO2" device.
  • Only "FreeO2" device in mode medical data collecting(SpO2)
Experimental: Experimental: device FreeO.
Automatic adjustment of oxygen
Device: FreeO2 v2.0 automatic adjustment
Other Names:
  • Automatic adjustment of oxygen through the "Free O2" device.
  • "FreeO2" device in mode medical data collecting(SpO2).

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: 6 hours or 1 hour after cessation of oxygenation
The target zone of oxygen saturation is : SpO2 = 92-98% The "acute phase of treatment" is defined by the 6 first hours of treatment by oxygenation and/or until one hour after the end of this last.
6 hours or 1 hour after cessation of oxygenation

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of complications related to the administration of oxygen
Time Frame: 28 days max
28 days max
Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).
Time Frame: 6 hours or 1 hour after after cessation of oxygenation
6 hours or 1 hour after after cessation of oxygenation
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Time Frame: 6 hours or 1 hour after oxygenation cessation
6 hours or 1 hour after oxygenation cessation
Oxygen consumption measured at the end of administration
Time Frame: 6 hours or 1 hour after cessation of the oxygenation
6 hours or 1 hour after cessation of the oxygenation
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

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 (Actual)

December 24, 2014

Primary Completion (Actual)

February 23, 2017

Study Completion (Actual)

February 23, 2017

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Infant-FreeO2

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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