Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorCharite University, Berlin, Germany

About this trial

Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 -100 years

Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany

Written informed consent to participate after having been properly instructed

Disqualifiers

Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study

Accommodation in an institution due to an official or judicial order

Insufficient knowledge of German language

Members of the hospital staff

Trial population

Male and female patients undergoing surgery, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 2 trial groups
Group A: Study group
Group B: Control group I

Trial outcomes

Primary outcomes

1

Neurocognitive Disorder (NCD)

Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.

Time frame
Up to 1 year
2

Postoperative cognitive dysfunction (POCD)

Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.

Time frame
Up to 1 year

Secondary outcomes

1

Suspected neurocognitive disorder due to MiniCog

The MiniCog is used for cognitive screening. A cut-off value of \<3 points is interpreted possible mild / major NCD. The Mini-Cog consists of a sub-test for word memory skills and a clock drawing test.

Time frame
Up to 5 years
2

Suspected dementia from MOCA

The Montreal Cognitive Assessment (MOCA) with cut-offs according to normative age-adjusted values is used as dementia screening. The MOCA consists of 13 items, which are rated on a scale from 0 to 30 points.

Time frame
Up to 5 years
3

Neurocognitive Disorder (NCD)

Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.

Time frame
Up to 5 years
4

Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')

The non-computerized neuropsychological trail making test is used as an indicator screening test for relevant cognitive changes after the operation. The cut-off is an increase in TMT-B test performance of\> 55 seconds three and / or 12 months after the operation compared to the baseline value.

Time frame
Up to 5 years

Other outcomes

1

Demographics

Demographics are measured by demographic data.

Time frame
Up to 5 years
2

Neurological diseases

Neurological diseases are taken from the hospital record

Time frame
Up to 5 years
3

Waist circumference

Waist circumference is measured in cm.

Time frame
Up to 5 years
4

Hip circumfernece

Hip circumference is measured in cm.

Time frame
Up to 5 years

Sponsors and contacts

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