N/A, measurement of blood pressure with a finger cuff n/a Non invasive blood pressure monitoring
Conditions
Interventions
None listed
Sponsors
Edwards Lifesciences LLC
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Children in the age 0-2 years during anesthesia for a planned surgery
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As the study is an early feasibility data collection, the primary outcome of the study is the confirmation that the design works and is able to measure blood pressure continously and non-invasively in children 0-2 years old. Measurement accuracy is determined by comparing the ClearSight blood pressure reading to a standard blood pressure reading. | — |
Secondary
| Measure | Time frame |
|---|---|
| Aspects such as ease of use will also be evaluated | — |
Countries
Netherlands
Outcome results
None listed