Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04360213 |
| Other study ID # |
2020-3403 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
September 2, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The primary objective of this study is to assess the function and reliability of a
non-invasive, skin-like electronic sensor.
We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively,
and rapidly assess critical vital signs and other measures essential to healthcare monitoring
for patients with asthma and anaphylaxis.
Description:
In clinical and home settings sensors to monitor vital parameters (including heart rate, ECG,
respiratory rate, temperature, and pulse oximetry) require the application and removal of
multiple, often bulky apparatuses. Furthermore, each requires constant, wired attachment to a
power supply and operators, which can limit visibility and impair the ability to move a
patient without interference. Serial measurements require significant time, as several
devices with separate leads are applied and removed to obtain measurements. Due to the
varying and often large measurement heads of different devices, readings may not be obtained
at exactly the same skin location, which impairs comparability of serial measurements.
Additionally, the process of measurement can disturb the skin area being measured.
Asthma and anaphylaxis are common entities in children. During exacerbations, frequent
monitoring of the vital parameters described is necessary to guide medical decision-making.
Asthma exacerbations are associated with mild to severe symptoms that include cough, wheeze,
tachypnea, retractions, labored breathing and respiratory fatigue. Food allergy reactions are
potentially severe with life-threatening symptoms of anaphylactic shock that include,
choking, respiratory distress and loss of consciousness. In the most severe cases reactions
can be fatal or require emergency and intensive care treatment in the hospital. Convenient,
easy to use, vital signs monitors are especially important in pediatric populations as
children have less ability to self-monitor or describe their physical symptoms of
life-threatening anaphylaxis or asthma exacerbation.
The wearable sensors offer a new, non-invasive and easy to use way to monitor vital signs of
patients with asthma and anaphylaxis. Our previous experience testing our wearable vital sign
sensors in multiple pediatric and neonatal studies since 2016, have shown a strong
correlation to existing standard of care monitor data outputs. Additionally, the sensors have
received positive feedback from patients and physicians, on their comfort, ease of use, and
application.
