ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of the Routine Use of Extubation Protocol on the Incidence of Occurrence of Failures Number of Extubation in Pediatric Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03129815
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : April 26, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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 between 4 and 22% failures. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. The extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. It allows the harmonization of practices in service (previously left to the discretion of each doctor).

The investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.


Condition or disease
Respiratory Insufficiency

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017



Primary Outcome Measures :
  1. Failure of extubation [ Time Frame: need for a new intubation within the first 48 hours after extubation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129815


Contacts
Contact: Anne-Sophie Guilbert, MD 33 (0)3 88 12 73 20 anne-sophie.guilbert@chru-strasbourg.fr
Contact: Lucie PETITDEMANGE 33 (0)3 88 12 73 20 lucie.petitdemange@chru-strasbourg.fr

Locations
France
Service de Reanimation Pediatrique Specialisee - S. Continue Recruiting
Strasbourg, F, France, 67091
Contact: Anne-Sophie Guilbert, MD    33 (0)3 88 12 73 20    anne-sophie.guilbert@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03129815     History of Changes
Other Study ID Numbers: 6360
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
extubation
pediatric resuscitation
reintubation
failures of extubation.

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases