Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints
Exersides 的商业化、采用、许可和制造
基本信息
- 批准号:10516414
- 负责人:
- 金额:$ 193.08万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-30 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdoptionAgitationAlzheimer&aposs DiseaseAlzheimer&aposs disease related dementiaAmerican Medical AssociationAmputationAnatomyBlood VesselsBreathingCaregiversCaringCessation of lifeChemicalsClinicalClinical TrialsCodeCognitiveCollaborationsCommunicationConsultConsultationsContractsCounselingCritical IllnessDeliriumDementiaDevelopmentDevice DesignsDevicesDistance EducationEarly MobilizationsEducationElderlyEngineeringEnteral FeedingEnvironmentEquipmentExcisionExhibitsFamily NursingFamily memberFeedbackFreedomGoalsGrowthHospitalsHumanImmobilizationImpaired cognitionIncidenceIndustrializationInfrastructureIntensive CareIntensive Care UnitsInternationalInterventionIntravenousLeadLegalLegal patentLicensingMarket ResearchMechanical ventilationMedicalMedical DeviceMethodsModelingMovementMuscle WeaknessOutcomePatientsPharmaceutical PreparationsPhasePhysical FunctionPhysical RestraintPilot ProjectsPositioning AttributePreventionProcessProductionReadinessResearchResourcesRiskRisk FactorsSedation procedureSmall Business Technology Transfer ResearchSourceSpecialistSyndromeSystemTestingTubeWristarmclinical practicecommercializationcost effectivedecubitus ulcerdesigneconomic outcomeendotrachealexperienceimprovedinnovationmodifiable riskmortalitymulti-site trialnew technologynovelpandemic diseasephase 1 testingphase I trialpreventresponserestraintsafe patientsatisfactionsedativetoolusability
项目摘要
ABSTRACT
The goal of this NIA STTR Commercialization Readiness Pilot is to traverse the Valley of Death in the early
Launch period of Healthy Design’s commercialization to market a novel arm restraint alternative in older
critically ill mechanically ventilated or confused patients that increases mobility; reduces agitation, use of
sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family
members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to
prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal tube.
This sedation and immobility lead to complications, including delirium and muscle weakness, that are
independently associated with long-term cognitive impairment, reduced physical functioning, and mortality.6-15
Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with
long-term cognitive impairment that is similar to Alzheimer’s Disease and Related Dementias.12,15
Healthy Design has developed the novel Exersides™ Refraint™ that allows arm mobility while keeping the
patient safe from entanglement in the vital tubes and lines attached to the patient.162-164 Because it permits
mobility, Exersides™ may reduce agitation and the need for sedatives. In a Pilot Study and a Phase I testing,
Exersides™ has demonstrated very encouraging results. The objectives of this CRP project are to create the
infrastructure necessary to meet production requirements and sustain independent growth. Now in Phase
II/Year II of its clinical trial, Healthy Design is preparing for imminent Launch.
This project has high potential to lead to a paradigm shift in the care of older critically ill or confused patients by
demonstrating that a novel restraint device reduces physical and cognitive impairment.
抽象的
NIA STTR 商业化准备试点的目标是在早期穿越死亡之谷
Healthy Design 商业化的启动期,旨在向老年人推销新型手臂约束替代品
重症机械通气或神志不清的患者可增加活动能力,减少躁动;
镇静药物和谵妄;并且在医院工作人员和家属中表现出很高的满意度和可接受性
老年机械通气患者通常通过手腕约束来固定。
防止自行拔管,并服用镇静剂以减少由约束装置和气管插管引起的躁动。
这种镇静和不动会导致并发症,包括谵妄和肌肉无力,
与长期认知障碍、身体功能下降和死亡率独立相关。6-15
具体而言,ICU 中谵妄的发生率和持续时间具有很强的独立性,并且与以下因素相关:
与阿尔茨海默病和相关痴呆症类似的长期认知障碍。12,15
Healthy Design 开发了新颖的 Exersides™ Refraint™,允许手臂活动,同时保持
患者不会被连接到患者身上的重要管子和管线缠住。162-164 因为它允许
在一项试点研究和第一阶段测试中,Exersides™ 可以减少躁动和镇静剂的需求。
Exersides™ 已展现出非常令人鼓舞的成果。该 CRP 项目的目标是创建
满足生产需求和维持独立增长所需的基础设施现已进入阶段。
Healthy Design 正在进行临床试验的第二年/第二年,正在为即将推出的产品做准备。
该项目很有可能通过以下方式导致老年危重患者或精神错乱患者的护理模式转变
证明一种新型约束装置可以减少身体和认知障碍。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Marie Pavini其他文献
Marie Pavini的其他文献
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{{ truncateString('Marie Pavini', 18)}}的其他基金
Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints
Exersides 的商业化、采用、许可和制造
- 批准号:
10260567 - 财政年份:2021
- 资助金额:
$ 193.08万 - 项目类别:
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