Early Feasibility Data Collection using ClearSight on Children Less than Two Years Old.
- Conditions
- /A, measurement of blood pressure with a finger cuffn/aNon invasive blood pressure monitoring
- Registration Number
- NL-OMON56297
- Lead Sponsor
- Edwards Lifesciences LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Children in the age 0-2 years during anesthesia for a planned surgery
1. Any significant disfigurement or prior injury to a participant*s finger that
is intended to be used for monitoring with the prototype finger cuff
2. Inability to place finger cuffs appropriately due to subject anatomy,
condition, or obstructive paraphernalia
3. Known sensitivities to system materials
4. Broken or open skin located at the site of the finger cuff
5. Proven left*right difference in blood pressure
6. Cardiac problems that can cause a difference in blood pressure between the
two arms, including aortic coarctation
7. Extreme contraction of the smooth muscles in the arteries and arterioles of
the lower arm and hand, such as may be present in patients with Raynaud*s
disease
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>As the study is an early feasibility data collection, the primary outcome of<br /><br>the study is the confirmation that the design works and is able to measure<br /><br>blood pressure continously and non-invasively in children 0-2 years old.<br /><br>Measurement accuracy is determined by comparing the ClearSight blood pressure<br /><br>reading to a standard blood pressure reading. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Aspects such as ease of use will also be evaluated</p><br>