Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-01 @ 3:50 AM
Study NCT ID:
NCT05625256
Status:
WITHDRAWN
Last Update Posted:
2023-08-07
First Post:
2022-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: