Neuroimaging Risk of Postoperative Delirium

NCT06236854 | Unknown

• 1 other identifier: NeuRO-POD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium (POD) is a frequent disorder of consciousness, arousal and attention in elderly patients following surgery. The glymphatic system is a newly discovered waste cleaning system of the brain. Glymphatic transport of CSF has been shown to be impaired by perioperative factors. Reduced glymphatic transport has been related to a vicious cycle of neuroinflammatory marker build-up, leading to increased glymphatic transport impairment, leading eventually to neuronal damage and hence cognitive impairment. Therefore, glymphatic transport impairment has been suggested to be an important mechanism underlying POD. But not everyone who undergoes surgery presents POD, so what makes certain patients susceptible to POD? It has been suggested that glymphatic transport may already be impaired at preoperative baseline, which, with the added burden of perioperative strain on the system, 'tilts' the patient into POD. The primary aim of the current study is to measure glymphatic transport in patients preoperatively and assess whether patients who present POD ('POD patients') show impairments in preoperative glymphatic transport, relative to patients who do not present POD ('noPOD patients'). Two aspects of glymphatic transport will be assessed using two noninvasive MR techniques - fast-acquisition BOLD-fMRI and DTI-MR. POD will be assessed using the 3D-CAM questionnaire and patients will also be assessed preoperatively for symptoms of depression, state/trait anxiety and cognitive status using standardised self-report measures.

Conditions

Post-operative Delirium

Outcome Measures

Primary Outcomes (1)

• Component of the brain waste clearance system as measured via magnetic resonance imaging

  Glymphatic system transport measured via diffusion tensor imaging/functional magnetic resonance imaging parameter of CSF flow coupling with global neurovascular activity at preoperative baseline is changed in POD-Present patients as compared with POD-Absent patients

  Morning prior to surgery during 30 minute MR protocol

Study Arms (2)

POD-Absent

The group of older-aged surgical patients who are not diagnosed with delirium as assessed for the following fives days post-surgery.

Other: Delirium assessment (observational, not interventional)

POD-Present

The group of older-aged surgical patients who are diagnosed with delirium as assessed for the following fives days post-surgery.

Other: Delirium assessment (observational, not interventional)

Interventions

Delirium assessment (observational, not interventional) OTHER

As an observational study, we will assess the presence of postoperative delirium in the enrolled patients, which will define their group membership.

POD-Absent; POD-Present

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older-aged elective surgical patients

You may qualify if:

• \>= 65 years of age
• Fluent in German
• Presence of at least one further risk factor for POD

You may not qualify if:

• Scheduled for neurological surgery
• Pre-existing neurological structural impairments or previous brain surgery
• ASA status 4
• Contraindication to MRI (e.g., pacemakers, artificial heart valves, cardioseal, aneurysm clips, implanted magnetic metal parts (screws, plates from surgery), cochlear implants, metal splitters/grenade splinters, acupuncture needle, insulin pump, piercings that cannot be removed, etc)
• Scheduled for emergency procedures
• Subjects with fear of confined spaces

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar der Technischen Universität München

München, Bavaria, 81675, Germany

RECRUITING

Related Publications (5)

• Fultz NE, Bonmassar G, Setsompop K, Stickgold RA, Rosen BR, Polimeni JR, Lewis LD. Coupled electrophysiological, hemodynamic, and cerebrospinal fluid oscillations in human sleep. Science. 2019 Nov 1;366(6465):628-631. doi: 10.1126/science.aax5440.

  PMID: 31672896 BACKGROUND

• Taoka T, Masutani Y, Kawai H, Nakane T, Matsuoka K, Yasuno F, Kishimoto T, Naganawa S. Evaluation of glymphatic system activity with the diffusion MR technique: diffusion tensor image analysis along the perivascular space (DTI-ALPS) in Alzheimer's disease cases. Jpn J Radiol. 2017 Apr;35(4):172-178. doi: 10.1007/s11604-017-0617-z. Epub 2017 Feb 14.

  PMID: 28197821 BACKGROUND

• Ren X, Liu S, Lian C, Li H, Li K, Li L, Zhao G. Dysfunction of the Glymphatic System as a Potential Mechanism of Perioperative Neurocognitive Disorders. Front Aging Neurosci. 2021 Jun 7;13:659457. doi: 10.3389/fnagi.2021.659457. eCollection 2021.

  PMID: 34163349 BACKGROUND

• Han F, Chen J, Belkin-Rosen A, Gu Y, Luo L, Buxton OM, Liu X; Alzheimer's Disease Neuroimaging Initiative. Reduced coupling between cerebrospinal fluid flow and global brain activity is linked to Alzheimer disease-related pathology. PLoS Biol. 2021 Jun 1;19(6):e3001233. doi: 10.1371/journal.pbio.3001233. eCollection 2021 Jun.

  PMID: 34061820 BACKGROUND

• Han F, Brown GL, Zhu Y, Belkin-Rosen AE, Lewis MM, Du G, Gu Y, Eslinger PJ, Mailman RB, Huang X, Liu X. Decoupling of Global Brain Activity and Cerebrospinal Fluid Flow in Parkinson's Disease Cognitive Decline. Mov Disord. 2021 Sep;36(9):2066-2076. doi: 10.1002/mds.28643. Epub 2021 May 17.

  PMID: 33998068 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gerhard Schneider, Prof

  Klinikum rechts der Isar der Technischen Universität München

  STUDY CHAIR

Central Study Contacts

Rachel Nuttall, PhD

CONTACT

0894140; rachel.nuttall@tum.de

Svenja Letz, Dr med

CONTACT

0894140; svenja.letz@mri.tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: February 1, 2024
• Study Start: October 9, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2023-10

Locations

DE (1)