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Central Venous Pressure (CVP) is a standard parameter for hemodynamic monitoring and is currently measured through the insertion of a catheter. The pediatric population is especially vulnerable to risks associated to this invasive procedure, including infection, thrombosis, and pneumothorax. The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device (CPMX2) in children equipped with an invasive catheter for CVP monitoring as part of standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPMX2 measurement arm | Experimental | CPMX2 measurements will be compared against invasive CVP measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPMX2 | Device | CPMX2 - Non-invasive pressure estimation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients. | Safety: Safety of the device shall be evaluated by systematically reporting DDs, ADEs and SADEs and by monitoring the frequency and incidence of these events. The practitioner will be asked to identify any new risks arising during the measurements using the investigational device. | Up to 4 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Preliminary accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP | Preliminary accuracy: Accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP will be evaluated against concomitant invasive CVP measurement with the standard of care catheter by computing the correlation coefficient and Bland-Altman analysis | Up to 4 days |
Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damon Judges | Contact | +41775071995 | d.judges@compremium.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17000916 | Background | Thalhammer C, Aschwanden M, Jaeger KA. Letter by Thalhammer et al regarding article, "External carotid artery-internal jugular vein fistula: a complication of internal jugular cannulation". Circulation. 2006 Sep 26;114(13):e517; author reply e518. doi: 10.1161/CIRCULATIONAHA.106.636571. No abstract available. |
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The investigator performing the measurement with CPMX2 is blinded to the invasive CVP measurement until the assessment is complete.
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