Letter by Thalhammer et al regarding article, "External carotid artery-internal jugular vein fistula: a complication of internal jugular cannulation".
Christoph Thalhammer, Markus Aschwanden, Kurt A Jaeger
https://pubmed.ncbi.nlm.nih.gov/17000916Actively Recruiting
Phase Not Applicable
Age: 0 - 21Years
All Genders
ID06885073
Non-invasive Central Venous Pressure Estimation in Pediatric Patients
Led by Compremium AG · Updated on 2025-09-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Central Venous Pressure (CVP) is an important measure used for monitoring blood flow and heart function, typically requiring insertion of a catheter. This procedure can pose risks such as infection, blood clots, and lung collapse, especially in children. This pilot study is designed to evaluate the safety and initial effectiveness of a new device called CPMX2, which uses ultrasound to estimate venous pressure without invasive catheters in pediatric patients who already have CVP catheters for standard care. The study involves comparing measurements from the CPMX2 device against the traditional invasive CVP measurements in children. Participants will have the CPMX2 device used externally on their neck to estimate venous pressure through ultrasound. The device's safety and accuracy will be evaluated over a period of up to 4 days while patients continue to receive standard catheter-based monitoring. Participants will be monitored closely during the study period, which lasts up to 4 days, to assess safety and compare CPMX2 readings with invasive CVP values. Researchers will check the external jugular venous occlusion pressure using the CPMX2 device and record any adverse effects. The study aims to provide preliminary data on whether this non-invasive method can safely and effectively estimate central venous pressure in children, potentially reducing the need for catheter use.
CONDITIONS
Brief Title
Non-invasive Central Venous Pressure Estimation in Pediatric Patients
Who Can Participate
Age: 0 - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Male or female
- Age from birth up to 21 years
- Equipped with a central venous catheter for CVP monitoring as part of standard care or undergoing cardiac catheterization
You will not qualify if you...
- Weight less than 2.5 kilograms at enrollment
- Both external jugular veins inaccessible due to vascular access or dressing
- Presence of bilateral skin lesions preventing neck ultrasound
- Active bleeding
- Clinically unstable as assessed by physician or surgeon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 4 days
Participants undergo non-invasive central venous pressure measurements using the CPMX2 device to estimate pressure.
Measurements performed during hospital stay as part of standard care
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
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Research Team
D
Damon Judges
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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