Skip to content

Effects of Positive End-Expiratory Pressure (PEEP) and Prone Positioning in Healthy Volunteers on Venous Hemodynamics Including the Venous Excess Ultrasound (VExUS) Score

Effects of Positive End-Expiratory Pressure (PEEP) and Prone Positioning in Healthy Volunteers on Venous Hemodynamics Including the Venous Excess Ultrasound (VExUS) Score

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07273617
Acronym
VeNIVPro
Enrollment
40
Registered
2025-12-09
Start date
2025-09-25
Completion date
2025-12-15
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Hemodynamics

Keywords

Positive End-Expiratory Pressure (PEEP), Venous Excess Ultrasound (VExUS) score, Venous congestion, Proning

Brief summary

The hemodynamic effects of proning and PEEP may vary depending on pre- existing cardiac function, lung mechanics, and volume status, and the available evidence remains conflicting. The impact on the VExUS score of these manoeuvres is unclear. This study aims to assess the effects of PEEP in supine and prone position on the VExUS score as well as echocardiographic parameters in a cohort of healthy volunteers.

Detailed description

Venous congestion: characterized by elevated venous pressure and impaired flow through the organs towards the right heart, contributes to organ dysfunction and is associated with adverse outcomes in critically ill patients. Historically, hemodynamic assessment has focused on the arterial side of circulation, giving less attention to venous hemodynamics. However, there is growing evidence that venous congestion is a mediator of adverse outcomes and contributes to end-organ damage. With increasing venous congestion, subsequent venous distension in the splanchnic circulation occurs and the pressure waveform of the right atrium is retrogradely transmitted into the distal venous circulation. The more venous congestion is present, the more pulsatility is transmitted into the periphery. This represents the backbone of the venous excess ultrasound (VExUS) score assessment. The VExUS score assessment therefore represents a multi-organ Doppler approach evaluating venous congestion by measuring the inferior vena cava (IVC) diameter, flow pattern of hepatic veins, portal vein and intra-renal veins by ultrasound. Heart lung interactions and implications on VExUS: the VExUS score as well as femoral and jugular vein flows are expected to be affected by positive pressure ventilation. The VExUS score correlates with the Mean systemic filling pressure (MSFP) as a surrogate for stressed volume, in other words the proportion of blood which contributes to creating pressure and blood flow. As right atrial pressure is influenced by Positive End-Expiratory Pressure (PEEP), one would expect elevated VExUS Scores with higher PEEP levels. Influence of position on hemodynamics: conflicting effects on the circulatory system mediated by prone positioning have been described; no data about VExUS Score assessment in prone position is available.

Interventions

DIAGNOSTIC_TESTapplication of PEEP: starting PEEP = 15 mbar

The application of PEEP will be delivered by a intensive care respirator with dedicated NIV- mode (Hamilton C1, Hamilton Medical AG, Bonaduz Switzerland) via mask (VariFit, Sleepnet Corporation, New Hampshire, USA) available in four sizes (S, M, L, XL). Pressure support will be set at 5 mbar, and trigger will be adjusted according to participants' comfort. Fraction of inspired oxygen will be 0.21. If starting PEEP = 15 mbar: 5 min stepwise increase of PEEP Measurements with decremental PEEP (15, 10, 5, 0 mbar)

DIAGNOSTIC_TESTapplication of PEEP: starting PEEP = 0 mbar

The application of PEEP will be delivered by a intensive care respirator with dedicated NIV- mode (Hamilton C1, Hamilton Medical AG, Bonaduz Switzerland) via mask (VariFit, Sleepnet Corporation, New Hampshire, USA) available in four sizes (S, M, L, XL). Pressure support will be set at 5 mbar, and trigger will be adjusted according to participants' comfort. Fraction of inspired oxygen will be 0.21. If starting PEEP = 0 mbar: Measurement with increasing PEEP (0, 5, 10, 15 mbar)

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Prospective explorative study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Voluntary participants ≥ 18 years in good overall health with no relevant organ dysfunction in their medical history and signed informed consent form.

Exclusion criteria

* Non-French or non-German speakers * Unable to provide informed consent * Body mass index \> 40kg/m * Self-reported pregnancy * History of pneumothorax * Previously participated in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in VExUS score at 0, 5,10 and 15 mbar during non-invasive ventilation (NIV) in the supine position.up to 15 minThe Venous excess ultrasound (VExUS) score is a grading system that uses ultrasound to non-invasively assess and quantify systemic venous congestion by evaluating the inferior vena cava, hepatic veins, portal veins, and renal veins. A patient receives a grade from 0 (no congestion) to 3 (severe congestion) based on findings like IVC diameter and Doppler waveforms from the veins.

Secondary

MeasureTime frameDescription
Change in VExUS score at 0, 5,10,15 mbar during non-invasive ventilation in the prone position compared to the supine position.up to 15 minThe Venous excess ultrasound (VExUS) score is a grading system that uses ultrasound to non-invasively assess and quantify systemic venous congestion by evaluating the inferior vena cava, hepatic veins, portal veins, and renal veins. A patient receives a grade from 0 (no congestion) to 3 (severe congestion) based on findings like IVC diameter and Doppler waveforms from the veins.

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORGregor Loosen, Dr. med.

University Hospital Basel, Intensive Care Unit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026