Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-27 @ 3:23 AM
Study NCT ID:
NCT04119193
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2019-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring
Sponsor:
Erasme University Hospital
Organization:
Study Overview
Official Title:
Agreement and Precision of a Novel Smartphone Application (OPTIBP) For Continuous Blood Pressure Monitoring: A Comparison With the Invasive Radial Arterial Catheter
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of an novel smartphone algorithm designed to estimate blood pressure based on collected optical signals on patients against the reference method, (radial arterial catheter) in patients admitted in the post anesthesia care unit after major surgeries.
Detailed Description:
The purpose of the study is to compare the blood pressure values measured by a mobile application used with a smartphone and the values measured by reference method, which is the radial arterial line
Patients admitted to the post-anesthesia care unit after major surgeries (Erasme hospital)
Patient's arterial pressure will be measured with both measurement methods (novel smartphone application and the invasive arterial line).
The placement of an arterial line is standard of care in the investigators institution for patients scheduled for major surgeries. These patients spend 24 hours in the post-anesthesia care unit after their surgery for acute care management. Patient's blood pressure will be measured in parallel (same arm) with the mobile application and with the reference equipment (radial arterial line). Measures will be done during five times ( so five times one minute of recordings).
Blood pressure values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.
Patients admitted to the post-anesthesia care unit after major surgeries (Erasme hospital)
Patient's arterial pressure will be measured with both measurement methods (novel smartphone application and the invasive arterial line).
The placement of an arterial line is standard of care in the investigators institution for patients scheduled for major surgeries. These patients spend 24 hours in the post-anesthesia care unit after their surgery for acute care management. Patient's blood pressure will be measured in parallel (same arm) with the mobile application and with the reference equipment (radial arterial line). Measures will be done during five times ( so five times one minute of recordings).
Blood pressure values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: