Blood Pressure
Conditions
Brief summary
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.
Detailed description
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old
Interventions
DEVICEClearSight baby cuff
Noninvasive device for continuous blood pressure monitoring
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proper cuff fit | 30 minutes of monitoring with study devices during scheduled surgery procedure | 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. |
| Cuff remains properly fitted for the duration of the study measurement | 30 minutes of monitoring with study devices during scheduled surgery procedure | The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants. |
| Measurement with monitor started without errors | 30 minutes of monitoring with study devices during scheduled surgery procedure | A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction. |
| Measurement stability within 10 mins | 30 minutes of monitoring with study devices during scheduled surgery procedure | The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction. |
| Early feasibility accuracy | 30 minutes of monitoring with study devices during scheduled surgery procedure | For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg. |
Countries
Netherlands
Outcome results
None listed