Clinical trial NCT02005692: A Pilot Study to Assess the DynaSense System
Official title: A Pilot Study to Assess the DynaSense System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Keywords: pressure ulcers
bed sores
patient turn protocol
patient movement
patient monitoring
Lead sponsor: Leaf Healthcare, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Centauri Medical, Inc.
First posted: 2013-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

  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.

Primary outcomes:
measure: Safety Primary Endpoint
timeFrame: Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.
measure: Turn Protocol Compliance
timeFrame: Subjects will be followed for the length of hospital stay which is expected to average 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
Study officials:
affiliation: El Camino Hospital
name: Michelle Pezzani, MD
role: PRINCIPAL_INVESTIGATOR
References: