Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Delirium
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Number of Participants With Postoperative Delirium
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports in patients undergoing different techniques of aortic valve replacement. Patients are followed 5 days postoperative with the 3D-CAM or until resolution of POD. Six months postoperatively, a follow-up by phone is planned for activity of daily living (ADL).
Detailed Description
A significant and often underrecognized complication after surgery is postoperative delirium (POD) causing increased morbidity and mortality. This is especially true for the older cardiac surgical patient, in whom the incidence of POD is up to 70%. Surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of POD. Transaortic valve replacement (TAVR) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. However, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (SAVR) compared to TAVR, suggesting a reduced incidence of POD with TAVR compared to SAVR. In contrast, other studies found almost no difference in POD in the aforementioned patient groups. Hence, it remains still unclear which technique best to use in patients at high risk for POD.
Investigators
dr. Danny Hoogma
Anesthesiologist
Universitaire Ziekenhuizen KU Leuven
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled to undergo elective
- •SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))
- •Patient able to read and understand the research materials
Exclusion Criteria
- •Inability to give informed consent
- •Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)
- •Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)
Outcomes
Primary Outcomes
Number of Participants With Postoperative Delirium
Time Frame: Until the fifth postoperative day in hospital (an average of 5 days). In case of POD, followup was continued until resolution of POD or discharge (whichever comes first) up to 19 days.
Using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) and nurse reports combined with interview with the caregivers and patient
Secondary Outcomes
- Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days(Until 30 days postoperatively)
- Intensive Care Unit (ICU) Length of Stay(Until 30 days postoperatively)
- Duration of POD(If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge)
- Assessment of Instrumental Activities of Daily Living During 6-months Interview(6 months postoperatively)
- Hospital Length of Stay(Until 30 days postoperatively)
- Onset Moment of Postoperative Delirium(During the first five postoperative days)
- Severity of POD(If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge)
- Count of Patients Discharged Directly Home(Until 30 days postoperatively)
- Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months(6 months)