Pressure Ulcers
Conditions
Keywords
pressure ulcers, bed sores, patient turn protocol, patient movement, patient monitoring
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.
Interventions
DEVICEDynaSense sensor
Sponsors
Centauri Medical, Inc.
Leaf Healthcare, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Primary Endpoint | 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. |
| Turn Protocol Compliance | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DynaSense Sensor All subjects who successfully completed the study. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discharged earlier than anticipated | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DynaSense Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 33 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Safety Primary Endpoint
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DynaSense Sensor | Safety Primary Endpoint | 2.86 percentage of subjects with ADEs |
Primary
Turn Protocol Compliance
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DynaSense Sensor | Turn Protocol Compliance | 98 percentage turn compliance |