Cognitive Impairment Following Elective Spine Surgery (CONFESS)

Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren

Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.

It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.

Study Overview

• Status: Terminated
• Conditions: Cognitive Impairment; Postoperative Delirium; Spine Fusion

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.

Description

Inclusion Criteria:

• age ≥ 60 years
• scheduled for elective spine surgery without opening the dura
• patient can give informed consent him-/herself
• German native speaker

Exclusion Criteria:

• dementia or neurodegenerative disease
• psychiatric disease
• prescription of CNS-active medication (e.g. antidepressants, antipsychotics, sedatives, alpha-1-antagonists)
• impossible to participate in follow-up
• participation in an interventional trial
• electronic or displacable metallic implants
• active neoplasm

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Delirium
No Delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative delirium - incidence	screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift	≤ 3 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative delirium - duration	screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift	≤ 3 days postoperatively or until delirium resolves
postoperative delirium - severity	rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious	≤ 3 days postoperatively or until delirium resolves
postoperative cognitive dysfunction - severity	CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus)	baseline and 3 months postoperatively
pre- and postoperative intelligence	MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B)	baseline and 3 months postoperatively
Markers of systemic inflammation	C-reactive protein, Interleukins, Tumor necrosis factor among others	≤ 2 days postoperatively
Markers of neuroinflammation	Glial fibrillary acidic protein among others	≤ 2 days postoperatively
Markers of oxidative and metabolic stress	Malondialdehyd	≤ 2 days postoperatively
Patient Reported Quality of life	PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating)	baseline and 3 months postoperatively
Patient Reported Quality of life - 2	SF-36 (Short Form 36)	baseline and 3 months postoperatively
Anxiety and depression	HADS (Hospital Anxiety and Depression Scale)	baseline and 3 months postoperatively
Frailty	Groningen Frailty Scale	baseline and 3 months postoperatively
Structural magnetic resonance imaging	White matter lesions	baseline and 3 months postoperatively
Functional magnetic resonance imaging	Resting state networks	baseline and 3 months postoperatively
Cerebral vasculature	Ultrasound of extra- and intracranial cerebral arteries	baseline
Genetic polymorphisms		baseline

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Robert Fleischmann, MD, Department of Neurology; Principal Investigator: Jonas Müller, MD, Department of Neurosurgery

Publications and helpful links

General Publications

• Muller J, Nowak S, Vogelgesang A, von Sarnowski B, Rathmann E, Schmidt S, Rehberg S, Usichenko T, Kertscho H, Hahnenkamp K, Floel A, Schroeder HW, Muller JU, Fleischmann R. Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial. JMIR Res Protoc. 2020 Feb 13;9(2):e15488. doi: 10.2196/15488. Erratum In: JMIR Res Protoc. 2020 Feb 28;9(2):e18469.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; delirium; quality of life; elderly; postoperative cognitive dysfunction; spine surgery; neuroinflammation; resting state fmri; cerebral vasculature
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction
• Other Study ID Numbers: BB 192/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No