iMRI Prone Positioning Frame Design Feasibility Study

NCT ID: NCT06388512

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-04
• Study Completion Date: 2025-09-04

Brief 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.

Detailed 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.

Conditions

Epilepsy; Pulmonary Embolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Prototype positioning device

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

Group Type: EXPERIMENTAL

prototype prone positioning device

Intervention Type: DEVICE

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

Interventions

prototype prone positioning device

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Continuum Educational Technologies

UNKNOWN

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kinsman, MD

Role: PRINCIPAL_INVESTIGATOR

mkinsman2@kumc.edu

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Central Contacts

Andrew Guillotte, MD

Role: CONTACT

aguillotte@kumc.edu

3096487036

Michael Kinsman, MD

Role: CONTACT

mkinsman2@kumc.edu

Facility Contacts

Andrew Guillotte, MD

Role: primary

aguillotte@kumc.edu

309-648-7036

References

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.

Reference Type: BACKGROUND

PMID: 31723910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25097742 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35011843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9149576 (View on PubMed)

Other Identifiers

STUDY00160044

Identifier Type: -

Identifier Source: org_study_id