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Completed

NCT Number: NCT04589767

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

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).

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PICU University Hospital of Padova

Padova, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAPD scale

Behavioral

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

Primary outcomes

  1. inter-evaluator agreement

    Time frame: 1 hour during PICU stay

    CAPD evaluation by two operators

  2. intra-evaluator agreement

    Time frame: 2 minutes during PICU stay

    CAPD evaluation by two operators

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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