Non-invasive Venous Pressure Estimation

Yale University40 enrolled

Overview

The non-invasive central venous pressure estimation in adult cardiac intensive care units (CICU) patients study is a single-center, single-arm, investigator-blinded, interventional, intra-participant comparative, feasibility study. This study aims to assess the safety and preliminary accuracy of external jugular venous occlusion pressure measured non-invasively with the venous occlusion pressure monitoring device (CPMX2) in adult CICU patients. As a feasibility study, the primary goal is to gather preliminary data on the feasibility, safety, and effectiveness of the non-invasive CVP estimation method. Although single arm, the study will compare non-invasive CVP measurements with standard invasive CVP measurements taken concurrently. This intra-participant comparative approach is essential to validate the correlation and reliability of the non-invasive method.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Cardiac Intensive Care

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed and dated informed consent * Admitted to the CICU with invasive CVP/RA pressure monitoring placed by standard of care as determined by the treating team before enrollment * No more than moderate TR as assessed by echocardiogram Exclusion Criteria: * Undergoing positive pressure ventilation (Bipap or invasive mechanical ventilation) * Non-visible external jugular vein bilaterally (by visual examination or with traditional ultrasound examination) * History of thrombosis in any of the following vessels bilaterally; external jugular vein, internal jugular vein, brachiocephalic vein or superior vena cava * Skin lesions, vascular access sites or dressings covering neck and impeding access to the external jugular veins at the level of the muscle belly of the sternocleidomastoid muscle

Outcomes

Primary Outcomes

Mean venous pressure to assess accuracy

Mean CPMX2 external jugular occlusion pressure will be compared to invasive CVP measurement in mmHg

Time frame: Day 1

Number of adverse events to assess safety

Safety measured by number of adverse events related to or potentially related to the study device and device deficiencies reported during study

Time frame: Day 1

Number of device deficiencies to assess safety

Safety measured by number of device deficiencies reported during study

Time frame: Day 1

Secondary Outcomes

Mean Point-of-care ultrasound (POCUS)-derived pressure measurements

Mean POCUS-derived pressure measurements as defined by current clinical guidelines (calculated using inferior vena cava (IVC) collapsibility and diameter measurements)

Time frame: Day 1

Non-invasive Venous Pressure Estimation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts