Delirium Detection in Pediatric Intensive Care Unit Throu... | NCT04954261

Studies
Delirium Detection in Pediatric Intensive Care Unit Through a French Translation of the CAPD : a French Monocentric Observational Study

NCT04954261

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Last Update Posted

Mar 12, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Delirium

Interventions

CAPD

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A00763-52	Other Identifier	ID-RCB

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Abandoned study project

Expanded Access Info

Start Date

Dec 6, 2018Actual

Primary Completion Date

Dec 6, 2018Actual

Completion Date

Dec 6, 2018Actual

First Submitted Date

Sep 7, 2018

First Submission Date that Met QC Criteria

Jul 5, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 12, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAPD	Diagnostic Test	CAPD evaluation every day per 12hours during their stay in PICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of delirium in the PICU population	Number of CAPD evaluated > 9 / total number of CAPD evaluated	2 months

Secondary Outcomes

Measure	Description	Time Frame
Applicability of the CAPD by the paramedics	5 questions : Whether or not they have already heard about delirium Whether or not they know the symptoms of delirium in children and adolescents Whether or not they have already been confronted to a state of delirium in the Pediatric Intensive Care Unit Whether of not they think it would be useful to have a specific scale to diagnose delirium in the Pediatric Intensive Care Unit Whether or not they think it would be feasible to use such a scale regularly in the Pediatric Intensive Care Unit The proposed answers will be Yes, No or I don't know for each question The analysis will be qualitative and quantitative.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients aged 0 to 18 years hospitalized in PICU at Necker Children's Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laure De Saint Blanquat, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necker Enfants Malades Hospital		Paris		75015	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided