Blood Pressure
Conditions
Brief summary
A prospective, non-randomized single arm study using the investigational ClearSight NextGen (CSNG) system in adult subjects.
Interventions
DEVICEClearSight NextGen system
Study devices will be applied to subjects for monitoring for the duration of the procedure.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Age ≥ 18 years 3. Planned or existing monitoring with an arterial catheter as part of standard of care 4. Patient scheduled to undergo surgery with general anesthesia lasting \> 2 hours
Exclusion criteria
1. Any significant disfigurement or prior injury to a participant's finger that is intended to be used for monitoring with the study finger cuffs 2. Known left-right difference in blood pressure 3. 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 4. Patients deemed not suitable for the study at the discretion of the Investigator 5. Participation in another study that clinically interferes with the current study 6. Treatment with an intra-aortic balloon pump 7. Pregnancy 8. Cardiac surgery including bypass period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection for Development of ClearSight NextGen System | Monitoring during surgery, for up to approximately 4 hours. | The objective of the study is to collect systolic and diastolic blood pressure data using the investigational CSNG system alongside CE-Marked ClearSight and FloTrac devices in adult subjects. |
Countries
United Kingdom
Outcome results
None listed