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A Pilot Study to Assess the DynaSense System

Primary Purpose

Pressure Ulcers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DynaSense sensor
Sponsored by
Leaf Healthcare, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pressure Ulcers focused on measuring pressure ulcers, bed sores, patient turn protocol, patient movement, patient monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    1. Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR
    2. Be postmenopausal for at least 2 years, OR
    3. have had a bilateral tubal ligations, OR
    4. have had a bilateral oophorectomy, OR
    5. 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.

Sites / Locations

  • El Camino Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DynaSense sensor

Arm Description

Outcomes

Primary Outcome Measures

Safety Primary Endpoint
The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.
Turn Protocol Compliance
The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2013
Last Updated
August 10, 2014
Sponsor
Leaf Healthcare, Inc.
Collaborators
Centauri Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02005692
Brief Title
A Pilot Study to Assess the DynaSense System
Official Title
A Pilot Study to Assess the DynaSense System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leaf Healthcare, Inc.
Collaborators
Centauri Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
pressure ulcers, bed sores, patient turn protocol, patient movement, patient monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Pezzani, MD
Organizational Affiliation
El Camino Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States

12. IPD Sharing Statement

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A Pilot Study to Assess the DynaSense System

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