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The aim of the prospective study is to assess the feasibility of a screening and baseline measurement protocol that is planned for a main study (PRÄP-GO) in a collective of 30 patients ageing 70+ scheduled for elective surgery. Comprehensive geriatric assessment scores and modified Fried frailty phenotype component evaluation are performed in all patients at baseline before elective surgery. The assessment of cognitive tests is conducted with a battery of neuropsychological tests, computer-based tests from the Cambridge Neuropsychological Test Automated Battery [CANTAB®] and non-computer based tests. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty should be analyzed in this study and receive further comprehensive geriatric assessment testing up to seven days after surgery/discharge (before 7 postoperative days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 non-frail (robust) study patients | Patients fulfill 0 criteria according to modified Fried frailty score. | ||
| 10 pre-frail study patients | Patients fulfill 1-2 criteria criteria according to modified Fried frailty score. | ||
| 10 frail study patients | Patients fulfill 3, 4 or 5 criteria according to modified Fried frailty score. |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration to run the test battery | The duration of the screening test battery is measured with a stopwatch. | 1 day (Once only at screening) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of test battery | The study patient´s acceptance of the screening test battery is measured with a questionnaire. | 1 day (Once only at screening) |
| Problems to conduct the test battery |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Status | Neuropsychological testing | 1 day (Once only at screening) |
| Depression | The assessment of Depression is measured with the - Patient Health Questionnaire (PHQ-8) |
Inclusion criteria:
Exclusion criteria:
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Patients undergoing elective surgery aged ≥70 years, including 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty.
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD Prof. | Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité Univerisitätsmedizin Berlin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Problems while performing the test battery are categorized according to a standardized protocol.
| 1 day (Once only at screening) |
| Change in pain | Pain is measured with a pain score, a higher score indicates more pain. | Baseline, day 3 after surgery and discharge or day 7 after surgery |
| Intelligibility of the patient Diary 1 | Number of completed items | Up to day 7 after surgery |
| Intelligibility of the patient Diary 2 | Number of completed days | Up to day 7 after surgery |
| Intelligibility of the patient Diary 3 | Coherence of the diary with clinical patient record | Up to day 7 after surgery |
| Implementation rate of the patient Diary 3 | Up to day 7 after surgery |
| Handgrip strength | Handgrip strength measured using a Dynamometer. | Baseline, day 3 after surgery and discharge or day 7 after surgery |
| Mobility | Mobility is measured using the Charité Mobilitäts-Index (CHARMI®). | Baseline, day 3 after the operation and discharge or day 7 after surgery |
| Nutritional status 1 | Nutritional status 1 is measured using serum albumin. | Baseline and discharge or day 7 after surgery |
| Nutritional status 2 | Nutritional status 2 is measured using arm circumference. | Baseline and discharge or day 7 after surgery |
| Nutritional status 3 | Nutritional status 3 is measured using calf circumference. | Baseline and discharge or day 7 after surgery |
| Nutritional status 4 | Nutritional status 4 is measured using the Mini Nutritional Assessment - Short Form (MNA®-SF). | Baseline and discharge or day 7 after surgery |
| Intra- and postoperative organ complications | Up to 7 days after surgery |
| Length of intensive care unit stay | Participants will be followed for the duration of hospital stay, an expected average of 1 day. |
| Length of stay | Participants will be followed for the duration of hospital stay, an expected average of 7 days. |
| 1 day (Once only at screening) |
| Frailty | Frailty is operationalized using modified Fried frailty criteria. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. | 1 day (Once only at screening) |