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

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ClinicalTrials.gov Identifier: NCT04589767
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
angela amigoni, Azienda Ospedaliera di Padova

Study Description
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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).

Condition or disease Intervention/treatment
Delirium Behavioral: CAPD scale

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : August 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children admitted in PICU
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589767


Locations
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Italy
PICU University Hospital of Padova
Padova, Italy
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Investigators
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Principal Investigator: angela amigoni University Hospital Padova
More Information
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Responsible Party: angela amigoni, MD, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT04589767    
Other Study ID Numbers: 4792/AO/19
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by angela amigoni, Azienda Ospedaliera di Padova:
delirium
monitoring
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders