fMRI Feasibility Older Hip Fracture Surgery

NCT05081726 | Unknown

• 1 other identifier: 19087
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

An assessment of the feasibility of structural and functional magnetic resonance imaging (MRI) brain scans in older people who have recovered from and older people who never had delirium after hip fracture surgery

Conditions

Magnetic Resonance Imaging; Hip Fractures; Postoperative Delirium

Keywords

older people; postoperative delirium; Functional MRI

Outcome Measures

Primary Outcomes (1)

• Feasibility of MRI in older people following hip fracture surgery assessed by tolerability of transfer to scanner and the scanning process

  The feasibility of transferring participants to and achieving structural and functional MRI scans. Specifically we will assess the number of participants in whom scans were successfully achieved

  From time of consent to day after MRI scan which is up to 5 days

Secondary Outcomes (4)

• Abnormalities of functional connectivity

  Up to one month after scans have been achieved

• Pain assessment.

  From immediately prior to transfer to the MRI suite until return to own hospital bed which is approximately 2 hours

• Actual times taken to achieve scans

  Up to 60 minutes

• Participant feedback

  Two occassions. The first immediately after return from the MRI scan suite. The second will occur the day after scanning. Each will take 5 minutes.

Study Arms (2)

Never had delirium

Older people recovering from hip fracture surgery who did not have postoperative delirium

Diagnostic Test: Functional MRI

Recovered delirium

Older people recovering from hip fracture surgery who experienced delirium which has resolved

Diagnostic Test: Functional MRI

Interventions

Functional MRI DIAGNOSTIC_TEST

Series of MRI scans of the brain

Never had delirium; Recovered delirium

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older people recovering from hip fracture surgery

You may qualify if:

• Age ≥ 65 years
• Cognitively intact
• primary admission for hip fracture surgery

You may not qualify if:

• Cognitive impairment
• Less than moderate level of activities of daily living
• History of neurosurgery/significant head trauma
• Acutely unwell/moribund
• Presence of neurological diseases including overt stroke, dementia, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders.
• Postural or movement disorders likely to impede MRI scan
• Contraindications to MRI
• Complex fractures/multiple injuries

Sponsors & Collaborators

• University of Nottingham: lead

MeSH Terms

Conditions

Hip Fractures; Emergence Delirium

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; 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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rob Dineen, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abiodun Moronke Noah, FRCA

CONTACT

01158231011; abi.noah@nottingham.ac.uk

Iain K Moppett, DM

CONTACT

01158230959; iain.moppett@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: October 18, 2021
• Study Start: July 4, 2022
• Primary Completion: September 2, 2022
• Study Completion: December 6, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05