ClearSight Baby Cuff

Edwards Lifesciences15 enrolled

Overview

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.

A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Pressure

Interventions

ClearSight baby cuffDEVICE

Noninvasive device for continuous blood pressure monitoring

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent 2. Age \< 2 years 3. Availability of a standard blood pressure measurement as part of standard of care Exclusion Criteria: 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

Locations (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands, Netherlands

Outcomes

Primary Outcomes

Proper cuff fit

The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap.