Trial Outcomes & Findings for A Pilot Study to Assess the DynaSense System (NCT NCT02005692)
NCT ID: NCT02005692
Last Updated: 2014-08-13
Results Overview
The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.
Results posted on
2014-08-13
Participant Flow
Participant milestones
| Measure |
DynaSense Sensor
All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.
The rate of compliance with prescribed turning protocols was measured using the DynaSense System.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
DynaSense Sensor
All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.
The rate of compliance with prescribed turning protocols was measured using the DynaSense System.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Discharged earlier than anticipated
|
5
|
Baseline Characteristics
A Pilot Study to Assess the DynaSense System
Baseline characteristics by cohort
| Measure |
DynaSense Sensor
n=63 Participants
All subjects who successfully completed the study.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
DynaSense Sensor
n=70 Participants
All subjects enrolled in the study.
|
|---|---|
|
Safety Primary Endpoint
|
2.86 percentage of subjects with ADEs
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
DynaSense Sensor
n=63 Participants
All subjects enrolled in the study.
|
|---|---|
|
Turn Protocol Compliance
|
98 percentage turn compliance
Interval 97.0 to 99.0
|
Adverse Events
DynaSense Sensor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DynaSense Sensor
n=70 participants at risk
All subjects enrolled in the study.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema (Skin Redness)
|
1.4%
1/70 • Number of events 1 • Upon removal of the patient sensor (within 5 minutes of removal), the subject's skin was assessed for any ADEs.
If an ADE was present upon sensor removal, the subject's skin was re-assessed approximately 1 hour later prior to hospital discharge when possible. If re-assessment was not possible prior to discharge, a follow-up telephone call was made to subjects to determine time to resolution.
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.4%
1/70 • Number of events 1 • Upon removal of the patient sensor (within 5 minutes of removal), the subject's skin was assessed for any ADEs.
If an ADE was present upon sensor removal, the subject's skin was re-assessed approximately 1 hour later prior to hospital discharge when possible. If re-assessment was not possible prior to discharge, a follow-up telephone call was made to subjects to determine time to resolution.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation/Discomfort
|
2.9%
2/70 • Number of events 2 • Upon removal of the patient sensor (within 5 minutes of removal), the subject's skin was assessed for any ADEs.
If an ADE was present upon sensor removal, the subject's skin was re-assessed approximately 1 hour later prior to hospital discharge when possible. If re-assessment was not possible prior to discharge, a follow-up telephone call was made to subjects to determine time to resolution.
|
Additional Information
Barrett Larson, MD, Chief Medical Officer
Leaf Healthcare, Inc.
Phone: 650-701-3652
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60