Prone Positioning Device for Neurosurgery

Overseen By Michael Kinsman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 hours or longer per procedure

5 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are: * Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI? * Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prototype Prone Positioning Device for neurosurgery?

Research shows that using the prone position (lying face down) in surgeries can improve oxygen levels and blood flow to the brain, which is beneficial in neurosurgical procedures. Additionally, a modified prone position has been proposed to reduce complications during spine surgeries, suggesting that similar positioning devices could enhance surgical outcomes. ^{1 2 3 4 5}

Is the Prone Positioning Device for Neurosurgery generally safe for humans?

The research articles discuss adverse events in neurosurgery and the importance of tracking them, but they do not provide specific safety data for the Prone Positioning Device for Neurosurgery. Therefore, there is no relevant safety information available for this specific device. ^{6 7 8 9 10}

How is the Prototype Prone Positioning Device treatment different from other treatments for neurosurgery?

The Prototype Prone Positioning Device is unique because it is specifically designed to optimize the prone position for neurosurgery, which is becoming a standard posture for such procedures. This device aims to improve the surgeon's and anesthetist's experience by providing better access and reducing complications associated with traditional prone positioning methods. ^{1 2 5 11 12}

Research Team

Michael Kinsman, MD

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for patients undergoing neurosurgical procedures that require intraoperative magnetic resonance imaging (iMRI). Participants should be in need of prone positioning during their surgery. Specific conditions like pulmonary embolism, embolism, or epilepsy are being considered.

Inclusion Criteria

I am an adult getting a specific epilepsy treatment at KUMC.

Exclusion Criteria

Vulnerable populations including prisoners, pregnant women, and KUMC employees/students.

I am under 18 years old.

Weight above the safe threshold for the device (weight capacity will be determined through computational stress analysis prior start of the study)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are placed in the prone position on the prototype device during neurosurgical procedures utilizing intraoperative MRI

8 hours or longer per procedure

1 visit per procedure

Follow-up

Participants are monitored for skin and thromboembolic complications after each procedure

Until discharge

Immediately after each procedure

Treatment Details

Interventions

• Prototype Prone Positioning Device

Trial Overview The study is testing a new prototype device designed to position patients face-down (prone) during brain surgeries with iMRI. It aims to determine if the device is practical and safe compared to standard pads used for such procedures.

Participant Groups

Group I: Prototype positioning device Experimental Treatment 1 Intervention

The prototype prone positioning device will be used during neurosurgical procedures utilizing intraoperative MRI.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Continuum Educational Technologies

Collaborator

Trials

1

Recruited

5+

Findings from Research

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

In the first 18 months after FDA approval of the Charité artificial disc, the reported rate of adverse events was relatively low, starting at 0.58% and peaking at 2.34%, indicating a manageable safety profile for this lumbar arthroplasty device.

The most common adverse event was anterior migration requiring reoperation (0.65%), but overall rates of adverse events were lower than those reported in the initial investigational studies, suggesting that the device's real-world performance may be better than initially anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first 18 months following food and drug administration approval of lumbar total disc replacement in the United States: reported adverse events outside an investigational device exemption study environment. Blumenthal, SL., Guyer, RD., Geisler, FH., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Modified prone position using lateral brace attachments for cervico-dorsal spine surgeries. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Surgery of the supratentorial and ventral spine: view-point of the surgeon]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

An Evidence-Based Protocol for Manual Prone Positioning of Patients With ARDS. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oxygenation and cerebral perfusion pressure improved in the prone position. [2007]

5. Germany pubmed.ncbi.nlm.nih.gov

New head-prone position for posterior fossa surgery in infants with severe hydrocephalus. [2019]

6. Austria pubmed.ncbi.nlm.nih.gov

A complication conference for internal quality control at the Neurosurgical Department of the University of Heidelberg. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The first 18 months following food and drug administration approval of lumbar total disc replacement in the United States: reported adverse events outside an investigational device exemption study environment. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse operative events in neurosurgical training: incidence, trends and proposals for prevention. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Contact dermatitis after the use of the PronePositioner. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Neurosurgical robotic arm drilling navigation system. [2018]