Validation of a Delirium Monitor

NCT02404181 | Completed DMC

• 1 other identifier: NL46622.041.13
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Keywords

Validation Studies; EEG

Outcome Measures

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

  4 days

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The source population will consist of frail, elderly patients (≥60 years) who will undergo elective surgery in the University Medical Center Utrecht, Isala Clinics Zwolle, Radboud University Medical Center Nijmegen, or Charité Universitätsmedizin Berlin, and who will be expected to remain admitted for at least two postoperative days. These patients will be informed on this study before admission to the hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• University Medical Center Nijmegen: collaborator
• Isala: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Numan T, van den Boogaard M, Kamper AM, Rood PJT, Peelen LM, Slooter AJC; Dutch Delirium Detection Study Group. Delirium detection using relative delta power based on 1-minute single-channel EEG: a multicentre study. Br J Anaesth. 2019 Jan;122(1):60-68. doi: 10.1016/j.bja.2018.08.021. Epub 2018 Oct 2.

  PMID: 30579407 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

NL (1)