Non-invasive Central Venous Pressure Estimation in Pediatric Patients
ConditionCentral Venous Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorCompremium AG
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Male or female
Age: birth to 21 years of age
Equipped with a central venous catheter (CVC) for central venous pressure (CVP) monitoring indication as part of standard of care, or undergoing cardiac catheterization.
Disqualifiers
Weight less than 2.5kg at the time of enrollment.
Bilateral external jugular veins not accessible due to vascular access or dressing.
Bilateral skin lesion contraindicating neck Ultrasound
Active bleeding
Trial design
Treatments tested in this trial
- CPMX2
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov