Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
Not provided
Not provided
Not provided
Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.
This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.
After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearSight feasibility testing | Device | A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions |
| Measure | Description | Time Frame |
|---|---|---|
| validation systole, diastole, mean ABP and pulse pressure | accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral) | within 1 hour |
| implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure | Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve | time during surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
Not provided
Not provided
Not provided
Patients in a perioperative setting already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| D.P. Veelo, Dr | Contact | 0031205662533 | d.p.veelo@amc.uva.nl |
| Name | Affiliation | Role |
|---|---|---|
| D.P. Veelo, Dr | inverstigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Recruiting | Amsterdam | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40012367 | Derived | Rellum SR, Noteboom SH, van der Ster BJP, Schuurmans J, Kho E, Vlaar APJ, Schenk J, Veelo DP. The hypotension prediction index versus mean arterial pressure in predicting intraoperative hypotension: A clinical perspective. Eur J Anaesthesiol. 2025 Jun 1;42(6):527-535. doi: 10.1097/EJA.0000000000002150. Epub 2025 Feb 27. | |
| 39411994 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rellum SR, Kho E, Schenk J, van der Ster BJP, Vlaar APJ, Veelo DP. A comparison between invasive and noninvasive measurement of the Hypotension Prediction Index: A post hoc analysis of a prospective cohort study. Eur J Anaesthesiol. 2025 Feb 1;42(2):131-139. doi: 10.1097/EJA.0000000000002082. Epub 2024 Oct 16. |
| 36174389 | Derived | Kho E, van der Ster BJP, van der Ven WH, Vlaar APJ, Immink RV, Veelo DP. Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure. J Clin Anesth. 2022 Dec;83:110976. doi: 10.1016/j.jclinane.2022.110976. Epub 2022 Sep 26. |