Respiratory InsufficiencyNCT03129802
Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation
An observational study of Respiratory Insufficiency, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Insufficiency
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Reanimation Pediatrique Specialisee - S. Continue
Strasbourg, 67091
Anne-Sophie Guilbert, MD, 33 (0)3 88 12 73 20, anne-sophie.guilbert@chru-strasbourg.fr
About this study
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.
- Conditions
- Respiratory Insufficiency
- Keywords
- extubation, pediatric resuscitation, reintubation, failures of extubation., Respiratory Insufficiency
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of extubation
Measured: need for a new intubation within the first 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129802
- Sponsor's protocol ID
- 6310
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Extubation Failure in Pediatric Resuscitation
- ClinicalTrials.gov ID
- NCT03129802
- Acronym / sponsor ID
- 6310
- Conditions
- Respiratory Insufficiency
- Keywords
- extubation, pediatric resuscitation, reintubation, failures of extubation., Respiratory Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of extubation
Time frame: need for a new intubation within the first 48 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie Guilbert, MD (33 (0)3 88 12 73 20, anne-sophie.guilbert@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of extubation (time frame: need for a new intubation within the first 48 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.