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

Not Applicable

Completed

• Conditions: Child Between 2 and 15 Years Old; Infant Between 1 Month and 24 Months Old; Hypoxemic Acute Respiratory Distress
• Interventions: Device: FreeO2 v2.0 data collecting; Device: FreeO2 v2.0 automatic adjustment

• Registration Number: NCT02302183
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-26
• Study Start: 2014-12-24
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual oxygenation	FreeO2 v2.0 data collecting	Manual adjustment of oxygen
Experimental: device FreeO.	FreeO2 v2.0 automatic adjustment	Automatic adjustment of oxygen

Primary Outcome Measures

Name	Time	Method
Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment	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 Outcome Measures

Name	Time	Method
Time spent in a area of severe desaturation (SpO2 <92%) and a hyperoxia area (SpO2> 98%).	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	6 hours or 1 hour after oxygenation cessation
Oxygen consumption measured at the end of administration	6 hours or 1 hour after cessation of the oxygenation
Number of complications related to the administration of oxygen	28 days max
Frequency of use of invasive or noninvasive ventilation during hospitalization	28 days max

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France