Ischemic Stroke
Conditions
Keywords
Ischemic Stroke, Motor Recovery, Length of Stay Reduction
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.
Interventions
DEVICEGuardian 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 .
Sponsors
TurnCare Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups | The time frame will be up to and including 24 months | The length of stay of acute ischemic stroke patients measured from the time of randomization until the the date of discharge or date of death from any cause, whichever came first. |
Countries
United States
Contacts
Primary ContactFern Cudlip, MSN FNP CNRN NVRN ANVP FNCS
Backup ContactLinda Seaman, MSN BSN RN CCRN
Outcome results
None listed