Delirium Clinical Trial
Official title:
Validation of a Delirium Monitor in Postoperative Elderly Patients
Verified date | May 2017 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Charite University, Berlin, Germany, Isala, University Medical Center Nijmegen |
Netherlands,
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 |
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