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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325413
Other study ID # PV5596
Secondary ID 01VSF16057
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date May 14, 2020

Study information

Verified date May 2021
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The focus of this study is the development of a perioperative treatment concept for elderly patients, based on individual necessities and risk factors, aiming to improve patient outcome. The planned interventions include preoperative screening for malnutrition, frailty and uncalled-for long-term medication, if required followed by early prophylaxis and treatment of these risk factors, prior to or during surgery.


Description:

In Germany every second inpatient surgical intervention is performed on patients aged 60 years and above. These patients often offer an extensive set of risk factors such as frailty, malnutrition, poor physical fitness and multi-morbidity that may in turn lead to longer hospitalizations and decline of health and functional status after surgery. An age-related increase in postoperative complications, such as postoperative cognitive dysfunction (POCD) and delirium is associated with a higher rate of postoperative morbidity, mortality and longer hospitalization. Early detection of risk factors and implementation of prophylactic measures is important to reduce postoperative complications and improve clinical outcomes in elderly patients. The aim of our study is to develop and verify a protocol - which allows for a systematic evaluation of risk factors and the implementation of prophylactic or therapeutic measures in order to optimize the postoperative outcome. The feasibility of our protocol will be verified in clinical practice by systematic process evaluations.


Recruitment information / eligibility

Status Completed
Enrollment 310
Est. completion date May 14, 2020
Est. primary completion date May 14, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Age >64 years - Written informed patients consent - forthcoming elective surgery - Time interval from inclusion to appointed surgery at least 5 days Exclusion Criteria: - Refusal of consent - Illiteracy - Poor knowledge ofGerman language - Mental disability - Vision handicap (not corrected) - Hearing handicap (not corrected) - Benzodiazepine abuse - Drug/ substance abuse - Psychosis - Parkinson disease - Emergency surgery - Planned postoperative ICU treatment - Planned inpatient stay 1 night - Cerebral surgery - Ophthalmological surgery

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Systematic inclusion of family members
Systematic inclusion of family members/ reference person in the perioperative process
Preoperative information
Detailed preoperative information about delirium prevention and procedures
Physical and breathing exercises
Preoperative execution of physical and breathing exercises if necessary
Dietary Supplement:
Dietary supplements
Dietary supplements if necessary
Other:
Evaluation of long-term medication
Avoidance of unsuitable drugs for elderly if possible
Procedure:
Regional anesthesia
Regional anesthesia whenever possible
Other:
Personal aids
Personal orientation aids until anesthesia induction
Device:
Temperature management
Perioperative warming
Neurmonitoring
Using Bispectral index (BIS) to measure the depth of anesthesia
Procedure:
Pain catheter
A pain catheter will be used as postoperative pain therapy if possible

Locations

Country Name City State
Germany Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE) Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of delivery of the intervention components Continuous documentation of which intervention components were delivered by the clincal staff with a standardized checklist 6 months
Other Experience of staff with intervention components Qualitative interviews with the clinical staff on acceptability, feasibility, barriers, and facilitators of the intervention 6 months
Other Mobility Timed Up&Go-Test Evaluation preoperatively, 1 month, 6 months after surgery
Other Physical fitness Sit-to-stand- Test Evaluation preoperatively, 1 month, 6 months after surgery
Other Grip strength Measurement by Vigorimeter Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Other Frailty LUCAS (Longitudinale Urbane Cohorten Alters - Studie) functional Index Evaluation preoperatively and 6 months after surgery
Other Mental Health Geriatric Depression Scale (GDS) by Yesavage: a 15-item self-report assessment used to detect depression in the elderly Evaluation preoperatively, 1 month, 6 months after surgery
Primary Functional abilities Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score Evaluation preoperatively, 1 month, 6 months after surgery
Secondary Cognitive impairment DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Secondary Attention and task switching The Trail Making Test A&B (TMT A&B): a neuropsychological test of visual attention and task alternation Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Secondary Attentional capabilities TAP Alertness: a computerized, standardized neuropsychological test for attentional performance. Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery
Secondary Health related quality of life Measured by a 12-item short-form (SF-12) Health Survey Evaluation preoperatively, 1 month, 6 months after surgery
Secondary Hospital length of stay Day of admission until day of discharge 1 month
Secondary Postoperative complications Incidence of postoperative complications Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery
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