Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

NeuroTherapia, Inc.

Status: Withdrawn

Conditions: Blood Pressure

Treatments: Device: SentiCor-300

Study type: Observational

Funder types: Other

Identifiers

NCT05625256

22-511

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia

Description:

To compare noninvasive 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 various positions.

Treatment:

Device: SentiCor-300