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Completed

NCT Number: NCT02302183

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

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.

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Key information

Conditions

Hypoxemic Acute Respiratory Distress Child Between 2 and 15 Years Old Dyspnea Infant Between 1 Month and 24 Months Old Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreeO2 v2.0 automatic adjustment

Device

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

FreeO2 v2.0 data collecting

Device

Other names: Manual adjustment of oxygen without the assistance of the "FreeO2" device., Only "FreeO2" device in mode medical data collecting(SpO2)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Oxygen consumption measured at the end of administration

    Time frame: 6 hours or 1 hour after cessation of the oxygenation

  4. Number of complications related to the administration of oxygen

    Time frame: 28 days max

  5. Frequency of use of invasive or noninvasive ventilation during hospitalization

    Time frame: 28 days max

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: Infant-Free02

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 26, 2014
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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