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NCT03129802 Clinical Trial

Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation

Respiratory Insufficiency Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03129802
Other study ID # 6310
Secondary ID
Status Recruiting
Phase N/A
First received June 17, 2016
Last updated May 10, 2017
Start date July 2016
Est. completion date August 2017

Study information
Verified date June 2016
Source University Hospital, Strasbourg, France
Contact Anne-Sophie Guilbert, MD
Phone 33 (0)3 88 12 73 20
Email anne-sophie.guilbert@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is 4 to 22% failure. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. Some risk factors are well defined in the literature as the duration of intubation, ENT and neurological history, the persistence of a respiratory disease, a high level of sedation. Other factors are more controversial as age, ventilatory parameters just before extubation before extubation blood gases, the interest of a leak test.

Also pediatric populations are extremely heterogeneous, so the investigators would like to highlight to extubation failure risk factors in Hautepierre pediatric ICU to better support these high-risk children.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.

- Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.

Exclusion Criteria:

- Refusal to participate in the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Reanimation Pediatrique Specialisee - S. Continue Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure of extubation need for a new intubation within the first 48 hours after extubation
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