fMRI Feasibility Older Hip Fracture Surgery

• Conditions: Hip Fractures; Postoperative Delirium; Magnetic Resonance Imaging
• Interventions: Diagnostic Test: Functional MRI

• Registration Number: NCT05081726
• Lead Sponsor: University of Nottingham

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

Detailed Description

Postoperative delirium, an acute sate of confusion occurs with higher frequency in older people. Hip fracture surgery is a procedure associated with an increased risk of postoperative delirium.

In the study the feasibility of achieving structure and functional connectivity imaging of the brain, using magnetic resonance imaging, in older people who are recovering from hip fracture surgery will be assessed.

People who have recovered from post operative delirium and people who did not have postoperative delirium will be included.

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06
• Study Start: 2022-07-04
• Primary Completion: 2022-09-02
• Study Completion: 2022-12-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Age

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recovered delirium	Functional MRI	Older people recovering from hip fracture surgery who experienced delirium which has resolved
Never had delirium	Functional MRI	Older people recovering from hip fracture surgery who did not have postoperative delirium

Primary Outcome Measures

Name	Time	Method
Feasibility of MRI in older people following hip fracture surgery assessed by tolerability of transfer to scanner and the scanning process	From time of consent to day after MRI scan which is up to 5 days	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

Secondary Outcome Measures

Name	Time	Method
Pain assessment.	From immediately prior to transfer to the MRI suite until return to own hospital bed which is approximately 2 hours	An assessment of baseline pain levels and then repeat assessments of pain during transfer and the MRI scanning process using the numerical pain rating scale
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.	The participant experience will be explored via verbal feedback which will be documented by the accompanying researcher
Abnormalities of functional connectivity	Up to one month after scans have been achieved	Identify any differences in functional connectivity between the resolved delirium and the never delirium MRI scans
Actual times taken to achieve scans	Up to 60 minutes	An assessment of unforeseen constraints on time taken to scan