Validation of a Delirium Monitor

Delirium Clinical Trial

Official title:

Validation of a Delirium Monitor in Postoperative Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404181
• Other study ID #: NL46622.041.13
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: May 2, 2017
• Start date: March 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: May 2017
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Charite University, Berlin, Germany, Isala, University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		4 days