Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05625256
• Other study ID #: 22-511
• Status: Withdrawn
• Start date: June 2023
• Est. completion date: November 2024

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• SentiCor-300
Continuous blood pressure measurement with the SentiCor-300.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.	During hospital admission
Secondary	Change	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.	During hospital admission
Secondary	Calibration Duration	To determine how long an oscillometric calibration of the SentiCor-300 lasts.	During hospital admission
Secondary	Gender and Fitzpatrick index	To compare perform class analysis on accuracy versus gender and Fitzpatrick index.	During hospital admission