Validation of a delirium monitor in postoperative elderly patients
Completed
- Conditions
- confusionDelirium10012221
- Registration Number
- NL-OMON44951
- Lead Sponsor
- Intensive Care Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 114
Inclusion Criteria
Aged 60 years and older
Patients undergoing elective surgery in UMC Utrecht, Isala Klinieken in Zwolle, RadboudUMC in Nijmegen, or Charité Universitätmedizin in Berlin
Expected to stay at least 2 days in hospital after surgery.
Patients defined as frail according to the geriatrician
Exclusion Criteria
No communication possible due to 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
Isolation because of known carrier ship of a resistant bacterium
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameters are the sensitivity, specificity, and predictive<br /><br>values based on the Receiver Operating Characteristics (ROC) curve of the<br /><br>relative delta power with as reference standard the diagnosis delirium by the<br /><br>delirium expert. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Relative delta power vs. DRS-R-98 (measure of severity of delirium)<br /><br>- Relative delta power vs. VAS (0-10) likelihood for a patient to be delirious<br /><br>- Impact of measurement for patient based on a two-question questionnaire<br /><br>- Burden of measure between 0 (no burden) and 10 (unimaginable burden)<br /><br>- Duration of measurement between 0 (fine) and 10 (too long)</p><br>