NCT03129802

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 11, 2017

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

June 17, 2016

Last Update Submit

May 10, 2017

Conditions

Keywords

extubationpediatric resuscitationreintubationfailures of extubation.Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Failure of extubation

    need for a new intubation within the first 48 hours after extubation

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Reanimation Pediatrique Specialisee - S. Continue

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

April 26, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 11, 2017

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations