Improvement of Perioperative Care of Elderly Patients

Perioperative Care Clinical Trial

— PeriAge  

Official title:

Improvement of Perioperative Care of Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325413
• Other study ID #: PV5596
• Secondary ID: 01VSF16057
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Perioperative Care

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