Status:
COMPLETED
Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)
Lead Sponsor:
University Hospital, Brest
Conditions:
Hypoxemic Acute Respiratory Distress
Infant Between 1 Month and 24 Months Old
Eligibility:
All Genders
1-15 years
Phase:
NA
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02302183
Start Date
December 24 2014
End Date
February 23 2017
Last Update
March 3 2017
Active Locations (1)
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1
CHRU de Brest
Brest, France, 29609