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ID
Source
Brief title
Health condition
Heart diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Two primary endpints: Length of hospital stay after cardiac surgery, and incidence of detected delirium at the surgical ward
Secondary outcome
Hospital readmissions within 30 days after surgery; hospital-related costs related to delirium diagnosis, treatment of delirium and screening for underlying causes for delirium, and costs for hospital stay; ICU length of stay (hours), discharge location, hospital- and 30-day mortality, delirium duration, Netherlands Heart Registry in-hospital endpoints for cardiac surgery, adherence to delirium protocol
Background summary
Delirium is a serious and common neuropsychiatric disorder (American Psychiatric Association, 2013) that is related to adverse long-term outcomes (Inouye, Westendorp, & Saczynski, 2014a). Postoperative delirium occurs often in hospitalized older patients following cardiac surgery, with an incidence in the postoperative period of 17% (including elective patients aged ≥45 years, (Koster, Hensens, Schuurmans, & Van Der Palen, 2012) and 13% (including elective adult patients,(ten Broeke, Koster, Konings, Hensens, & van der Palen, 2018)) respectively. Early detection of delirium enables early treatment of the underlying cause. Therefore, screening for delirium in patients at risk is an important part of clinical follow-up after surgery (Inouye, Westendorp, & Saczynski, 2014b; Marcantonio, 2017a; Nederlandse Vereniging voor Klinische Geriatrie, 2013; Samuel et al., 2015)
Although delirium screening is part of routine practice following cardiac surgery, patients with a hypoactive or mixed form of delirium are possibly missed (Marcantonio, 2017b). Current screening methods, such as the DOSS, are subjective. Although the DOSS is a sensitive instrument in research settings, during care-as-usual the sensitivity may decrease to 32% (Numan et al., 2017).
Recently, an objective medical device has been developed that can detect delirium based on a short one-channel EEG measurement: DeltaScan (Numan et al., 2019). Using DeltaScan in routine care may improve the delirium detection (Numan et al., 2019). Furthermore, improved detection of delirium may lead to improved patient outcomes such as length of stay and therefore to reduced hospital costs (Gleason et al., 2015; Lundstrom et al, 2005; Young & George, 2003).
In the present study, we aim to assess whether introduction of DeltaScan in routine clinical care as screening instrument for delirium, will (1) increase the reported incidence of delirium in the postoperative period, and (2) reduce hospital stay of delirious patients in the postoperative period at Thoraxcentrum Twente (TCT).
Study objective
The use of DeltaScan for delirium screening reduces length of hospital stay and increase the detection of delirium, in comparison with the Delirium Observation Scale
Study design
Surgical ward; 30-days after surgery
Intervention
Patients are screend for delirium with DeltaScan or the Delirium Observation Scale. The treatment of delirium is identical, and is according to hospital protocols.
Inclusion criteria
Patients over 70 years of age who received cardiac surgery (including TAVI patients with a thoracotomy) in the MST Thoraxcentrum Twente
Exclusion criteria
Patients who use lithium, have metal cranial implants, have dementia or other diseases that influence EEG measurements (i.e. acute brain damage) are excluded, because these are contraindications for DeltaScan use. Patients who opted-out of this study will be excluded as well.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9435 |
| Other | METC Twente : K20-58 |