A Pilot Study to Assess the DynaSense System

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Device: DynaSense sensor

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • El Camino Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DynaSense sensor	Device: DynaSense sensor

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Leaf Healthcare, Inc.
• Collaborators: Centauri Medical, Inc.
• Investigators: Principal Investigator: Michelle Pezzani, MD, El Camino Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (ESTIMATE): December 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 10, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: pressure ulcers; bed sores; patient turn protocol; patient movement; patient monitoring
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: CM-002