Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure

NCT05625256 | Withdrawn FDA Device

• 1 other identifier: 22-511
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Accuracy

  The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.

  During hospital admission

Secondary Outcomes (3)

• Change

  During hospital admission

• Calibration Duration

  During hospital admission

• Gender and Fitzpatrick index

  During hospital admission

Study Arms (1)

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

Interventions

SentiCor-300 DEVICE

Continuous blood pressure measurement with the SentiCor-300.

Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting adults scheduled for elective major surgery that requires an arterial catheter will be recruited into the study. There will be no restriction on race or ethnicity.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Officials

• Alparslan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 22, 2022
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share