Study of the Guardian System on Motor Recovery and Impact on Length of Stay in Ischemic Stroke Patients
NCT ID: NCT03673241
Last Updated: 2018-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-10-30
2019-03-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
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)
No interventions assigned to this group
Study Arm
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.
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 .
Interventions
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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 .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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TurnCare Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fern Cudlip, MSN FNP CNRN
Role: PRINCIPAL_INVESTIGATOR
Good Samaritan Hospital
Locations
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Good Samaritan Hospital
San Jose, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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. doi: 10.1097/00004647-199901000-00010.
Zheng Z, Yenari MA. Post-ischemic inflammation: molecular mechanisms and therapeutic implications. Neurol Res. 2004 Dec;26(8):884-92. doi: 10.1179/016164104X2357.
Nour M, Scalzo F, Liebeskind DS. Ischemia-reperfusion injury in stroke. Interv Neurol. 2013 Sep;1(3-4):185-99. doi: 10.1159/000353125.
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.
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.
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.
Other Identifiers
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18-6235
Identifier Type: -
Identifier Source: org_study_id
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