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

TurnCare

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Device: Guardian System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03673241

18-6235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Only Acute Ischemic Stroke Patients
• Baseline Modified Rankin Score of less than or equal to 0-2
• Remains hemiplegic (left or right) with motor component score on National Institute of Stroke Health Scale of 2-4 on arm/leg with or without thrombectomy/tissue plasminogen activator
• Insured (Medicare or private)

Exclusion criteria

• Dementia or Alzheimer Diagnosis
• Concurrent hemodialysis
• Obesity with Body Mass Index greater than 33
• Baseline Modified Rankin Score of 3 to 5
• Patients requiring ventilator support of greater than 2 days
• Peripheral neuropathy
• Concurrent deep vein thrombosis or venous thromboembolism
• Presence of concurrent pre-existing pressure injury
• Prolonged inconsistent use of perfusion therapy defined as two or more consecutive hours off of the perfusion enhancement device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control Group

No Intervention group

Description:

The Control Group will receive the standard support surface mattresses/bed surfaces and recovery chairs without the non-invasive perfusion enhancement system (The Guardian System)

Study Arm

Experimental group

Description:

The Study Arm will have the non-invasive perfusion enhancement system placed on their beds and recovery chairs. Patients will be utilizing the systems while lying in bed or sitting in the chair.

Treatment:

Device: Guardian System