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OpenTrials
Completed

NCT Number: NCT02005692

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Camino Hospital

Mountain View, California, 94040, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DynaSense sensor

Device

Primary outcomes

  1. Safety Primary Endpoint

    Time frame: Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.

    The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.

  2. Turn Protocol Compliance

    Time frame: Subjects will be followed for the length of hospital stay which is expected to average 5 days.

    The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.

Sponsors and collaborators

Lead sponsor

Leaf Healthcare, Inc.

Industry

Collaborators

  • Centauri Medical, Inc.

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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