A Pilot Study to Assess the DynaSense System

Study Overview
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Brief Summary
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The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that: the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns. the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn. the DynaSense system helps ensure compliance with an institution's established patient turning protocol.

Official Title
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A Pilot Study to Assess the DynaSense System

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Device: DynaSense sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female 18 to 110 years of age; Inpatient currently on the unit and expected to remain for at least 12 hours; Able and willing to comply with the study procedures; Subject (or his/her agent) is able to read, understand, and provide Informed Consent in the English language. Exclusion Criteria: Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding. Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR Be postmenopausal for at least 2 years, OR have had a bilateral tubal ligations, OR have had a bilateral oophorectomy, OR have had a hysterectomy. Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products. Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso. Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD). Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject. Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion. Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study. Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DynaSense sensor<br> | Device: DynaSense sensor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Primary Endpoint | The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events. | Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE. | 
| Turn Protocol Compliance | The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system. | Subjects will be followed for the length of hospital stay which is expected to average 5 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure ulcers, bed sores, patient turn protocol, patient movement, patient monitoring