Blood Pressure
Conditions
Brief summary
To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.
Detailed description
Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor Main study: Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements. Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.
Interventions
DEVICESentiCor-300
Continuous blood pressure measurement with the SentiCor-300.
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical indication for arterial catheter insertion; * Age ≥18 years; * American Society of Anesthesiologists (ASA) physical status class ≤3; * Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women; * Planned length of surgery \>60 minutes; * Anticipated supine positioning; * Anticipated initial recovery in the post-anesthesia care unit.
Exclusion criteria
* Severe peripheral vascular disease; * Surgery that involves manipulation of large arteries * Bypass surgery * Positive Allen's test * Inability to insert a catheter into an upper extremity artery; * Patients with an arterial-venous shunt for hemodialysis; * Inability to measure NIBP on the arm with the arterial catheter; * Atria l fibrillation; * Body Mass Index (BMI) \>35kg/m2; * Esophageal or nasopharyngeal pathology, coarctation of the aorta; * Emergency surgery. * Surgery which involves manipulation of major arteries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | During hospital admission | The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change | During hospital admission | Comparison of continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements during hemodynamic changes at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various postures and positions. |
| Calibration Duration | During hospital admission | To determine how long an oscillometric calibration of the SentiCor-300 lasts. |
| Gender and Fitzpatrick index | During hospital admission | To compare perform class analysis on accuracy versus gender and Fitzpatrick index. |
Outcome results
None listed