NCT03673241

Study of the Guardian System on Motor Recovery and Impact on Length of Stay in Ischemic Stroke Patients

A Randomized, Non-Blinded Clinical Trial of a Non-Invasive Perfusion Enhancement System (Guardian System) on Motor Recovery and Impact on Length of Stay in Mobility Impaired Ischemic Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: TurnCare Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-blinded randomized study that will investigate whether the use of a novel, non-invasive perfusion enhancement system (The Guardian System) impacts motor recovery and hospital length of stay in acute ischemic stroke patients.

Detailed description

This clinical research study is a prospective, non-blinded randomized clinical trial. The study protocol and consent form have been approved by the IRB at the Study Institution. As per the study design, consecutive adult patients admitted to the neuro-intensive care unit, with acute ischemic stroke, meeting the inclusion and exclusion criteria will be consented and enrolled in the study. Both the Study and Control groups will receive the standard of care for ischemic stroke according to the hospitals' protocols, policies and procedures. After obtaining informed consent, patients in the study arm will have the non-invasive perfusion enhancement system (The Guardian System) placed on their beds and chairs. The inflatable surfaces (the enhancers) will be placed directly on the mattress and chair under the fitted sheet and bed linens. They will be secured with a non-porous, non-slip silicone attacher. An adaptive pressure controller will be attached to the perfusion enhancer through a connector set. The adaptive pressure controller will be secured to the bed foot board or side rail and have the ability to be secured to an Intravenous pole as necessary. Specific data points for each patient in the Experimental group will be entered into the Controller: they include the patient's weight in kilograms and the patient's position (bed or chair). This study seeks to evaluate the device's effect on motor recovery and length of stay in a homogeneous ischemic stroke population that will be randomized for use of the novel non-invasive perfusion enhancement device from admission to discharge.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Guardian System	The Study arm will have the Guardian system applied to their bed and recovery chair with the intent for the patient to have the inflatable surface utilized underneath them .

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-01-30
• Completion: 2019-03-28
• First posted: 2018-09-17
• Last updated: 2018-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study