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OpenTrials
Completed

NCT Number: NCT02404181

Validation of a Delirium Monitor

Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized by physicians and nurses, even when screening instruments are used. Electroencephalography (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG registration with three electrodes and automatic processing can distinguish patients with delirium from patients without delirium very well. However, these findings need to be validated in an unselected population.

The primary objective of this validation study is to investigate the sensitivity, specificity, and predictive values of the EEG-based delirium monitor (including three electrodes and a reference electrode) compared to delirium quantification in frail elderly patients after surgery.

In an international multicenter study, 154 frail elderly patients will be included who will undergo elective surgery and are expected to remain admitted for at least two postoperative days. Patients are excluded if communication is not possible or admitted for neurological surgery.

A five minute EEG registration with the delirium monitor with four electrodes will be performed prior surgery and three consecutive days after surgery or until discharge. Within one hour of the EEG recording, the delirium assessment will be performed and recorded on video, which will be evaluated by delirium experts. The relative delta power (calculated from one minute of artifact-free EEG segment) will be compared with the conclusion of the delirium experts.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 60 years and older
  • Frail
  • Undergoing elective surgery
  • Expected to remain admitted for at least 2 postoperative days

Exclusion criteria

  • No communication possible due to a language barrier or deafness
  • Admission for neurological surgery
  • Participation in this study during a previous hospital admission
  • Practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor
  • Isolation because of known carrier ship of a resistant bacterium

Treatment and study plan

Primary outcomes

  1. Relative delta power (based on 1 min. artifact-free data) will be compared to the classification of the delirium expert in elderly postoperative patients resulting in the sensitivity, specificity and predictive values of the delirium monitor for each day

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Charite University, Berlin, Germany
  • Isala
  • University Medical Center Nijmegen

Registry information

Official study title

Validation of a Delirium Monitor in Postoperative Elderly Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2015
Registry last updated
May 3, 2017

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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