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NCT Number: NCT04563858

Polish Validation 4AT Tool

Delirium is a phenomenon which affects patients with various disorders and representing various age groups. Screening instruments make it possible to diagnose the condition at an early stage and to prevent its development. The aim of the study is to examine the reliability and validity of the Polish version of the 4AT (Pol4-AT) in patients after cardiac surgery.

Procedure of validation:

After obtaining the author's consent, the original English version of the 4AT was separately translated by 3 centres working on the validation of the Pol4-AT (University of Rzeszów, Poland; University Hospital in England; Karolinska University, Sweden). Then, three translations were compared, to be approved by the project supervisor (Karolinska University). Any doubts arising during the comparison were consulted with the English translator. As a result, one coherent version was accepted and translated back into English. The questionnaire was distributed in a convenient sample of 20 patients to examine the validity of the face. Vague words and statements were changed, and the final version translated into Polish was created. The Pol4-AT was tested for internal consistency and reliability.

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Key information

Conditions

Delirium, Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Procedure

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Rzeszow University Institute of Health Sciences

Rzeszów, Warzywna Saint 1, 35-310, Poland

About this study

Delirium, which generally is triggered by underlying medical conditions, is an acute and fluctuating disorder associated with attention and cognitive defects, and frequently accompanied by excessive arousal and perception-related problems. Delirium may lead to a variety of complications, e.g. cognitive impairments. Development of delirium is promoted by both anaesthesia and pain. Patients subjected to cardiac surgeries are at risk of delirium due to such factors as extracorporeal circulation applied during the intervention and various cardiovascular complications. Rapid identification of the problem may help eliminate avoidable complications which can be prevented at an early stage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults
  • able to sign the consent form
  • elective cardiac surgery
  • extracorporeal circulation

Exclusion criteria

  • unconscious patients
  • diagnosed mental illness
  • patient's lack of consent to participate in the study

Treatment and study plan

Validation

Diagnostic Test

Assessment of Polish version of the 4AT

Primary outcomes

  1. Validity for the Polish version 4AT

    Time frame: third day following a surgery

    The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course.

    A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.

  2. Reliability for the Polish version 4AT

    Time frame: third day following a surgery

    The Pol4-AT questionnaire consists of 4 items assessing four aspects of delirium: alertness, short mental test, attention, acute change or fluctuating course.

    A 4AT total score of 0 indicates that delirium or cognitive impairment is unlikely; a score between 1 and 3 indicates possible cognitive impairment and a score ≥ 4 is suggestive of delirium.

Sponsors and collaborators

Lead sponsor

Andrzej Frycz Modrzewski Krakow University

Other

Collaborators

  • Karolinska Institutet
  • University of Rzeszow

Registry information

Official study title

Interdisciplinary Treatment Towards a Patient With Delirium

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
Feb 6, 2024

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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