Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

Withdrawn

• Conditions: Blood Pressure
• Interventions: Device: SentiCor-300

• Registration Number: NCT05625256
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-22
• Study Start: 2023-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07
• Primary Completion: 2023-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia	SentiCor-300	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.

Primary Outcome Measures

Name	Time	Method
Accuracy	During hospital admission	The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.

Secondary Outcome Measures

Name	Time	Method
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.