Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

NCT ID: NCT05625256

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-11-30

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.

Conditions

Blood Pressure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia

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.

SentiCor-300

Intervention Type: DEVICE

Continuous blood pressure measurement with the SentiCor-300.

Interventions

SentiCor-300

Continuous blood pressure measurement with the SentiCor-300.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alparslan Turan, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

22-511

Identifier Type: -

Identifier Source: org_study_id