NCT05625256

Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	SentiCor-300	Continuous blood pressure measurement with the SentiCor-300.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2022-11-22
• Last updated: 2023-08-07

Regulatory

• FDA-regulated device study