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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03673241
• Other study ID #: 18-6235
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: March 28, 2019

Study information

• Verified date: September 2018
• Source: TurnCare Inc.
• Contact: Fern Cudlip, MSN FNP CNRN NVRN ANVP FNCS
• Phone: 408-724-0979
• Email: Fern.cudlip[@]hcahealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 28, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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 .

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
TurnCare Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

Bharucha JB, Seaman L, Powers M, Kelly E, Seaman R, Forcier L, McGinnis J, Nodiff I, Pawlak B, Snyder S, Nodiff S, Patel R, Squitieri R, Wang L. A Prospective Randomized Clinical Trial of a Novel, Noninvasive Perfusion Enhancement System for the Prevention of Hospital-Acquired Sacral Pressure Injuries. J Wound Ostomy Continence Nurs. 2018 Jul/Aug;45(4):310-318. doi: 10.1097/WON.0000000000000450. — View Citation

Davies CA, Loddick SA, Toulmond S, Stroemer RP, Hunt J, Rothwell NJ. The progression and topographic distribution of interleukin-1beta expression after permanent middle cerebral artery occlusion in the rat. J Cereb Blood Flow Metab. 1999 Jan;19(1):87-98. — View Citation

Doll DN, Barr TL, Simpkins JW. Cytokines: their role in stroke and potential use as biomarkers and therapeutic targets. Aging Dis. 2014 Oct 1;5(5):294-306. doi: 10.14336/AD.2014.0500294. eCollection 2014 Oct. Review. — View Citation

Du T, Zhu YJ. The regulation of inflammatory mediators in acute kidney injury via exogenous mesenchymal stem cells. Mediators Inflamm. 2014;2014:261697. doi: 10.1155/2014/261697. Epub 2014 Apr 15. Review. — View Citation

Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507. Review. — View Citation

Jiang LP, Tu Q, Wang Y, Zhang E. ???????Ischemia-reperfusion injury-induced histological changes affecting early stage pressure ulcer development in a rat model. Ostomy Wound Manage. 2011 Feb;57(2):55-60. — View Citation

Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97. Review. — View Citation

Nour M, Scalzo F, Liebeskind DS. Ischemia-reperfusion injury in stroke. Interv Neurol. 2013 Sep;1(3-4):185-99. doi: 10.1159/000353125. Review. — View Citation

Zheng Z, Yenari MA. Post-ischemic inflammation: molecular mechanisms and therapeutic implications. Neurol Res. 2004 Dec;26(8):884-92. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups	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.	The time frame will be up to and including 24 months