Clinical trial NCT04954261: Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study
Official title: Implementing Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Delirium
Keywords: Delirium
paediatric intensive care unit
CAPD (Cornell Assessment of Paediatric Delirium)
French translation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 0 to 18 years hospitalized in PICU at Necker Children's Hospital

Brief summary: The purpose of this study is to introduce delirium detection and try to determine the prevalence of delirium in Pediatric Intensive Care Unit (PICU) using a validated tool : the Cornell Assessment of Pediatric Delirium (CAPD) for every patient twice a day.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of delirium in the PICU population
timeFrame: 2 months
Secondary outcomes:
measure: Applicability of the CAPD by the paramedics
timeFrame: Before inclusion period
measure: Applicability of the CAPD by the paramedics after the 2 months period
timeFrame: 2 months
measure: Use of the CAPD by the paramedics
timeFrame: 2 months
measure: Age
timeFrame: 2 months
measure: Sex
timeFrame: 2 months
measure: Term of birth
timeFrame: 2 months
measure: Prior neurological impairment
timeFrame: 2 months
measure: Diagnosis (motivating hospitalization in intensive care)
timeFrame: 2 months
measure: Severity score on arrival (PIM 3)
timeFrame: 2 months
measure: Daily severity score (PELOD 2)
timeFrame: 2 months
measure: Duration of hospitalization
timeFrame: 2 months
measure: Death or survival of the patient
timeFrame: 2 months
measure: Mechanical ventilation, non invasive ventilation or spontaneous ventilation
timeFrame: 2 months
measure: Mechanical ventilation time
timeFrame: 2 months
measure: Presence of parents
timeFrame: 2 months
measure: Presence of pain
timeFrame: 2 months
measure: withdrawal or not
timeFrame: 2 months
measure: Use of benzodiazepines, ketamine, corticosteroids or opioids
timeFrame: 2 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Enfants Malades Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laure De Saint Blanquat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: