Clinical trial NCT03673241: Study of the Guardian System on Motor Recovery and Impact on Length of Stay in Ischemic Stroke Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Motor Recovery
Length of Stay Reduction
Lead sponsor: TurnCare Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, non-blinded, randomized trial. This cohort will be divided into two groups: (1) The Control Group (2) The Study Group
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups
timeFrame: The time frame will be up to and including 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
Study officials:
affiliation: Good Samaritan Hospital
name: Fern Cudlip, MSN FNP CNRN
role: PRINCIPAL_INVESTIGATOR
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