- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954261
Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study (DeliReP)
Implementing Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study
Study Overview
Detailed Description
Delirium is a frequent affection in ICU. In adult population, its prevalence is 20-50% in non intubated patients and 60-80% in patients under invasive ventilation. It is also frequent in paediatric population, but less diagnosed, whereas it can lead to higher duration stay, higher morbidity, traumatic injuries, acute stress, memory losses and post-traumatic stress syndrome. Since 2016, international guidelines recommend to look for delirium in paediatric population in PICU. There are 3 recommended tools to diagnose this affection: psCAM-ICU (6 months-5 years old), pCAM-ICU (5 years old-18 years old) and CAPD (birth-18 years old).
None of these validated tools have been translated in French.
The principal objective is to study the practicability of twice a day detection of delirium in PICU using the CAPD.
Investigators will first used a validation process to translate the CAPD in French, based on the validation method for psychological questionnaires suggested by Vallerand.
Then they will ask the paramedics to evaluate through the CAPD every consecutive patient/12 hours, every day during their stay in PICU, except for those completely unresponsive or under curare. This systematic evaluation will take place for 2 consecutive months.
For every patient, data will be collected about their age, sexe, term of birth, mental affection status, diagnosis at entry, and daily risk of mortality score, length of stay, ventilation, pain evaluation and treatment, withdrawal evaluation, surroundings, use of hypnotic treatment, steroids, opioids and ketamine.
The secondary aims are to determine the prevalence of delirium with the data collected, to ask whether or not the French version of CAPD has been easily and correctly used, can help to diagnose delirium, and whether investigators can find some associated parameters to delirium.
Study Type
Contacts and Locations
Study Locations
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Paris, France, 75015
- Necker Enfants malades hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being hospitalized in PICU during the inclusion period
- Age 0 to 18 years old
Exclusion Criteria:
- Patient with a state of sedation that does not allow the assessment of a change in the state of consciousness or cognitive functioning (equivalent score Richmond Agitation-Sedation Scale RASS <-3 or COMFORT B <11)
- Patient or Parental opposition to the observational study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of delirium in the PICU population
Time Frame: 2 months
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Number of CAPD evaluated > 9 / total number of CAPD evaluated
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Applicability of the CAPD by the paramedics
Time Frame: Before inclusion period
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5 questions :
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Before inclusion period
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Applicability of the CAPD by the paramedics after the 2 months period
Time Frame: 2 months
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The same 5 questions of the pre-test, 5 new closed-ended questions and 3 open-ended questions :
1- If difficulties of evaluating patients with the CAPD : quote the difficulties 2- In which categories of patients do they think that the CAPD in not adapted 3- Comment or suggestions to improve the use of the scale |
2 months
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Use of the CAPD by the paramedics
Time Frame: 2 months
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% of CAPD completed during the 2 months period
|
2 months
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Age
Time Frame: 2 months
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Potential associated factors to delirium
|
2 months
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Sex
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Term of birth
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Prior neurological impairment
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Diagnosis (motivating hospitalization in intensive care)
Time Frame: 2 months
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Potential associated factors to delirium
|
2 months
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Severity score on arrival (PIM 3)
Time Frame: 2 months
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Potential associated factors to delirium.
Pediatric Index of Mortality (PIM) 3 is a published and open acces program whith 10 variables about the patients (7 binary variables and 3 quantitative ones), that predicts the death probability of the patient.
One evaluation per patient at the admission in the PICU unit.
|
2 months
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Daily severity score (PELOD 2)
Time Frame: 2 months
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Potential associated factors to delirium.
PELOD 2 (PEdiatric Logistic Organ Dysfunction) is a published and open acces program that includes ten variables corresponding to five organ dysfunctions.
It predicts a daily percentage of mortality.
One evaluation per day per patient during the PICU unit stay.
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2 months
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Duration of hospitalization
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Death or survival of the patient
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Mechanical ventilation, non invasive ventilation or spontaneous ventilation
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Mechanical ventilation time
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Presence of parents
Time Frame: 2 months
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Potential associated factors to delirium
|
2 months
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Presence of pain
Time Frame: 2 months
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Potential associated factors to delirium. Pain was evaluated through the appropriate scale amongst :
Patients able to assess pain felt :
|
2 months
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withdrawal or not
Time Frame: 2 months
|
Potential associated factors to delirium.
Withdrawal was evaluated through the scale WAT-1 (Wthdrawal Assessing tool version 1): ten items scored 0 or 1, and 1 item scored 0 to 2, a total score greater than or equal to 3/12 indicating a state of withdrawal.
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2 months
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Use of benzodiazepines, ketamine, corticosteroids or opioids
Time Frame: 2 months
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Potential associated factors to delirium
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2 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Laure De Saint Blanquat, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI18018J
- 2018-A00763-52 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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