F05.8
Conditions
Interventions
Group 1: • Age = 70 years
• Male and female patients
• Patients who have been included in QV-POD-2 (https://clinicaltrials.gov/study/NCT04355195)
• Patients capable of giving consent for inclusion
Sponsors
Klinik für Anästhesiologie und Intensivmedizin (CCM/CVK), Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: Study patients: • Patients who have been included in QV-POD • Patients capable of giving consent for inclusion: Consent given by the patient, preoperatively with verbal and written consent form before the start of data collection • Surgery (elective) For the Nutrition Subproject – BF1000 Scale Analysis: Inclusion criteria: • Age = 70 years • Male and female patients • Patients enrolled in the QV-POD study For the Actigraphy/Chronotype/Circadian Rhythm Disorders Subproject: Inclusion criteria: (i) = 70 years old, (ii) planned primary joint replacement or revision surgery (aseptic or septic) on the hip or knee, (iii) there is an interval of at least 8 days between the eligibility assessment and the planned surgery date, (iv) sufficient knowledge of German. For the Cognition subproject: Non-surgical comparison cohort: Inclusion criteria: -Age = 70 years -No elective surgery planned -No surgery within the last 12 months prior to study enrollment -ASA I-III
Exclusion criteria
Exclusion criteria: Study patients: • Terminally ill patients (palliative situation) • Insufficient German language skills • Intracranial procedures For the Nutrition Subproject – BF1000 Body Composition Analysis: Exclusion criteria: • Criteria for BIA measurement: No drug pumps or other electronic implants, no medical implants (no pacemakers), not pregnant, = 200 kg For the subproject on actigraphy/chronotype/circadian rhythm disorders: Exclusion criteria: (i) severe, uncontrolled visual impairments, (ii) transition to or from daylight saving time < 2 weeks before surgery, (iii) Travel involving a time zone change prior to surgery with too short a time interval between arrival and surgery (depending on the number of time zones crossed): • 1–3 time zones: Exclusion if arrival < 14 days before surgery • 4–6 time zones: Exclusion if arrival < 16 days before surgery • = 7 time zones: Exclusion if arrival is < 20 days before surgery For the Cognition subproject: -Patients with terminal illnesses or in late-palliative care situations (expected death during the follow-up period), -Patients with a neuropsychiatric condition or severe hearing and/or visual impairment (not compensated by hearing or visual aids) that limits the ability to perform neurocognitive testing -Insufficient German language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determination of the phenotype of each case of delirium or non-delirium • Delirium = incidence of delirium using validated delirium screening instruments (NuDESC, DSM-V, CAM/CAM-ICU, 3D-CAM, DDS, ICDSC), hypo- or hyperactive delirium using RASS. A mixed form is defined that fluctuating hypo- and heyperactive states appear. • Subsyndromal delirium = defined by the score results of ICDSC and DDS. • No delirium/positive resilience = corresponds to negative delirium screening and the absence of symptoms of delirium. [Time Frame: Up to and including the fifth postoperative day or until discharge, if the discharge date is before the fifth postoperative day.] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of neurocognitive disorder Incidence of neurocognitive disorder according to DSM-5 criteria for mild/major neurocognitive disorder is measured by paper penicl and/or computerbased cognitive testing with CANTAB web based testing. Cognitive self-care is assessed using Multifactorial Memory Questionnaire and Informant Questionnaire on cognitive Decline in the Elderly, while complex everyday skills are assessed using the geriatric scales IADL according to Lawton and Brody and the B-ADL score.In addition, neuropsychiatric symptoms are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) and the Mini-DIP to identify mild behavioral deficits. [Time Frame: Up to one year] 2. Severity of delirium 1 Quantified using validated scores from electronic patient records. [Time Frame: Up to and including the fifth postoperative day or until discharge, if the discharge date is before the fifth postoperative day.] 3. Delirium severity 2 Delirium severity according to many validated scores and psychopathological assessment based on the AMDP system and/or retrospective review of the medical chart. [Time Frame: Until discharge from hospital/transfer to external follow-up treatment] 4. Duration of delirium Determined by medical and neuropsychological progress assessment measurements [Time Frame: Up to and including the fifth postoperative day or until discharge, if the discharge date is before the fifth postoperative day.] 5. Documentation of the etiological differential diagnoses for delirium (infection, withdrawal, metabolic derailment, etc.) based on doi: 10.1016/S2213-2600(18)30062-6. [Time frame: Up to and including the fifth postoperative day or until discharge, if the discharge date is before the fifth postoperative day. 6. Chronological sequence and perioperative course of delirious symptoms [Time frame: Up to and including the fifth postoperative day or until discharge, if the discharge date is before the fifth postoperative day. 7. | — |
Countries
Germany
Contacts
Public ContactClaudia Spies
Klinik für Anästhesiologie und Intensivmedizin (CCM/CVK), Charité - Universitätsmedizin Berlin
Outcome results
None listed