iMRI Prone Positioning Frame Design Feasibility Study

Epilepsy Clinical Trial

Official title:

Intraoperative MRI Prone Position Support Frame Design Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388512
• Other study ID #: STUDY00160044
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Andrew Guillotte, MD
• Phone: 3096487036
• Email: aguillotte[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Laser Interstitial Thermal Therapy (LITT) ablations are neurosurgical procedures which are performed for several indications including brain tumors and epilepsy. LITT procedures are performed utilizing intraoperative magnetic resonance imaging (MRI) scans. Some of these procedures must be performed in the prone position and can last 8 hours or longer. Investigators have observed several minor skin breakdown complications as well as a few major thromboembolic complications during these long prone procedures. Investigators hypothesize that the cause of the major thromboembolic complications are a result of compression of the femoral veins by the gel pads used to support the patient in the prone position. Many long spine surgeries are performed in the prone position and fewer episodes of skin pressure wounds are experienced and no major intraoperative thromboembolic complications. The study team hypothesizes that the difference is the way that the spine surgery pads support the hips does not compress the femoral vein, therefore significantly decreasing the risk of developing a thrombus intraoperatively.

The aim of this project is to design a modular, adjustable plastic frame to support the spine surgery Jackson table chest and hip pads. Investigators will produce a prototype of the frame and test it during LITT procedures. The prototype of the frame will be 3D printed using the 3D printer owned by the Department of Neurosurgery. The hypothesis is that supporting the patient in the prone position using similar positioning methods to those used for spine surgeries will reduce the rate of skin pressure injuries and prevent future major thromboembolic complications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients undergoing prone laser interstitial thermal therapy procedures for epilepsy at the University of Kansas Medical Center (KUMC).

Exclusion Criteria:

• Patients under the age of 18

• Patients who are unable to provide informed consent for participation in the study

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

• Patients who do not speak English fluently enough to provide informed consent in English

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

Related Conditions & MeSH terms

• Embolism
• Epilepsy
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Continuum Educational Technologies

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cho JK, Han JH, Park SW, Kim KS. Deep vein thrombosis after spine operation in prone position with subclavian venous catheterization: a case report. Korean J Anesthesiol. 2014 Jul;67(1):61-5. doi: 10.4097/kjae.2014.67.1.61. Epub 2014 Jul 29. — View Citation

Gebhard CE, Zellweger N, Gebhard C, Hollinger A, Chrobok L, Stahli D, Schonenberger CM, Todorov A, Aschwanden M, Siegemund M. Prone Positioning as a Potential Risk Factor for Deep Vein Thrombosis in COVID-19 Patients: A Hypothesis Generating Observation. J Clin Med. 2021 Dec 25;11(1):103. doi: 10.3390/jcm11010103. — View Citation

Hong B, Yoon SH, Park SY, Song S, Youn A, Hwang JG. Cardiac Arrest from Patient Position Change after Spine Surgery on a Jackson Table. Acute Crit Care. 2019 Feb;34(1):86-91. doi: 10.4266/acc.2016.00794. Epub 2017 Feb 20. — View Citation

Kanter DS, Mikkola KM, Patel SR, Parker JA, Goldhaber SZ. Thrombolytic therapy for pulmonary embolism. Frequency of intracranial hemorrhage and associated risk factors. Chest. 1997 May;111(5):1241-5. doi: 10.1378/chest.111.5.1241. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of devices that meet functional requirements	The device will be evaluated for meeting its primary function during each use. The primary function is to support the patient in the prone position in the MRI machine during neurosurgical procedures. Whether it fulfills its function will be determined through feedback received from the staff involved in its use which may include nurses, MRI technologists, anesthesia providers, and surgeons. This will be a pass/fail criteria.	During and immediately after each through study completion, an average of 1 year
Primary	Number of devices that are damaged during use	The device will be inspected for physical damage during and after each use. It will be inspected for bending, cracks, mechanical wear, or any other type of damage which could affect the device's safety or ability to serve its primary function. The type and severity of the damage will be recorded after each use and evaluated by the investigators. This will be a pass/fail criteria.	During and immediately after each through study completion, an average of 1 year
Secondary	Number of patients with skin complications	Each patient's skin will be examined after each procedure to evaluate for pressure injuries related to the prone positioning device. Size and severity of the skin injuries will be documented.	Immediately after each procedure
Secondary	Number of patients with thromboembolic complications	Each patient will be monitored for thromboembolic complications such as deep vein thrombosis or pulmonary embolism.	During and after each procedure until the patient is discharged.