CPMX2 for Central Venous Pressure

(CPMX-CVP-Ped Trial)

Overseen By Damon Judges

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Compremium AG

Disqualifiers: Weight <2.5kg, Active bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called CPMX2, which could simplify and enhance the safety of monitoring central venous pressure (CVP) in children. Typically, CVP is checked with a catheter, which carries risks such as infections. The new device uses ultrasound to measure CVP without inserting anything into the body. This trial involves children who already have a central venous catheter as part of their regular medical care. Participants must be stable and free of any neck skin issues that could interfere with the ultrasound. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve safety and comfort in medical monitoring for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound-based monitoring device is safe for children?

Research has shown that the CPMX2 device provides a safe and non-invasive method to measure central venous pressure (CVP). Previous studies have focused on its use in children and suggest that CPMX2 can estimate venous pressure without the risks associated with traditional methods, such as infection or blood clots.

As a non-invasive device, CPMX2 avoids the complications of catheter insertion, the standard method for measuring CVP. So far, no serious side effects have been reported with CPMX2, making it a promising tool, especially for children who require careful monitoring without the added risk of invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CPMX2 because it offers a non-invasive way to measure central venous pressure (CVP), unlike the current standard, which requires invasive procedures like catheter insertion. This new method could significantly reduce the risk of complications associated with invasive monitoring. Additionally, CPMX2 could make CVP assessments more accessible and comfortable for patients, potentially providing faster, real-time data for better clinical decision-making.

What evidence suggests that the CPMX2 device is effective for monitoring central venous pressure?

Studies have shown that measuring central venous pressure (CVP) is crucial for monitoring conditions like sepsis. The usual method involves inserting a tube, which poses risks, especially for children. This trial will test the new device, CPMX2, as a safer alternative to estimate CVP using ultrasound, eliminating the need for insertion. This approach may avoid risks such as infections and blood clots. Early findings suggest that CPMX2 measures pressure almost as accurately as the traditional method. Although further research is necessary, the early results are promising for safer monitoring. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children and young adults from birth to 21 years old who already have a central venous catheter (CVC) in place or are undergoing cardiac catheterization. Participants must provide consent.

Inclusion Criteria

I am either male or female.

I have signed a consent form for the trial.

I am 21 years old or younger.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Measurement

Participants undergo non-invasive CPMX2 measurements compared against invasive CVP measurements

Up to 4 days

Follow-up

Participants are monitored for safety and effectiveness after measurements

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CPMX2

Trial Overview The study tests a new non-invasive device called CPMX2, which uses ultrasound to estimate Central Venous Pressure (CVP), aiming to reduce the risks associated with invasive catheters.

How Is the Trial Designed?

Group I: CPMX2 measurement arm Experimental Treatment 1 Intervention

CPMX2 measurements will be compared against invasive CVP measurements

Who Is Running the Clinical Trial?

Compremium AG

Lead Sponsor

Trials

5

Recruited

160+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06885073

Non-invasive Central Venous Pressure Estimation in ... The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device ...

2. withpower.com withpower.com/trial/phase-venous-pressure-central-2-2025-1ddf0

CPMX2 for Central Venous Pressure (CPMX-CVP-Ped Trial) The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7358999/

Central venous pressure measurement is associated with ... CVP measurement was associated with decreased risk-adjusted 28-day mortality among patients with sepsis and was proportionally mediated through serum lactate ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01079611

Non-invasive Assessments of Central Venous Pressure We will examine 77 consecutive patients with invasive venous access and invasive hemodynamic monitoring at the surgical intensive care unit (ICU). After ...

5. researchgate.net researchgate.net/publication/49798453_Comparison_of_Water_Manometry_to_2_Commercial_Electronic_Pressure_Monitors_for_Central_Venous_Pressure_Measurement_in_Horses

Comparison of Water Manometry to 2 Commercial ... These data show that both electronic monitors systematically provide measurements that are approximately 2 cmH₂O lower than water manometry, but ...

6. compremium.ch compremium.ch/

Compremium - Turning Point in Diagnostics CPMX-2. For Vessels. A non-invasive aid to directly measure pressure in vessels for diagnosing vascular conditions. Contact us. a person in a white coat and ...

7. compremium.ch compremium.ch/products-cpmx2

Platform Revolutionizing venous pressure measurement - non-invasive, precise and highly correlated with gold standard. Finally, a newstandard forunlocking ...

8. clinicaltrial.be clinicaltrial.be/fr/details/445727?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

EJV Occlusion Pressure Measurement to Assess ... The objective of this clinical investigation is to assess safety and feasibility of external jugular vein (EJV) occlusion pressure measured non- ...