NCT04589767

Brief Summary

70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

October 10, 2020

Last Update Submit

February 14, 2022

Conditions

Delirium

Keywords

deliriummonitoring

Outcome Measures

Primary Outcomes (2)

  • inter-evaluator agreement

    CAPD evaluation by two operators

    1 hour during PICU stay

  • intra-evaluator agreement

    CAPD evaluation by two operators

    2 minutes during PICU stay

Study Arms (1)

children admitted in PICU

children enrolled will be evaluated by two nurses using CAPD Italian version. One nurse will repeat the evaluation two minutes later.

Behavioral: CAPD scale

Interventions

CAPD scaleBEHAVIORAL

Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later

children admitted in PICU

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children admitted in PICU

You may qualify if:

  • PICU admission
  • Comfort Behavioral Score \> 11

You may not qualify if:

  • use of neuromuscular blocking agents at the moment of CAPD evaluation
  • Comfort Behavioral Score \< 11

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PICU University Hospital of Padova

Padua, Italy

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • angela amigoni

    University Hospital Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2020

First Posted

October 19, 2020

Study Start

January 1, 2020

Primary Completion

August 30, 2021

Study Completion

September 30, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)