Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

Sponsor

The Cleveland Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05625256

Collaborator

(none)

200

Enrollment

Location

10.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Device: SentiCor-300

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: SentiCor-300 Continuous blood pressure measurement with the SentiCor-300.

Arm

Intervention/Treatment

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.

Device: SentiCor-300

Continuous blood pressure measurement with the SentiCor-300.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator: Alparslan Turan, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT05625256

Other Study ID Numbers:

22-511

First Posted:

Nov 22, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Dec 5, 2022