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NCT04589767 Clinical Trial

Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language

Delirium Clinical Trial

Official title:
Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04589767
Other study ID # 4792/AO/19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date September 30, 2021

Study information
Verified date February 2022
Source Azienda Ospedaliera di Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Description:

The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic. In this study we aim to perform the psychometric validation. 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). The score will be recorded in a data collection card, all the cards will be collected and then analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - PICU admission - Comfort Behavioral Score > 11 Exclusion Criteria: - use of neuromuscular blocking agents at the moment of CAPD evaluation - Comfort Behavioral Score < 11

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy PICU University Hospital of Padova Padova

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary inter-evaluator agreement CAPD evaluation by two operators 1 hour during PICU stay
Primary intra-evaluator agreement CAPD evaluation by two operators 2 minutes during PICU stay
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