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NCT Number: NCT07273617

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Intensive Care Unit

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Gregor Loosen, Dr. med.

CONTACT

[email protected]

+41 61 328 40 90

Gregor Loosen, Dr. med.

PRINCIPAL_INVESTIGATOR

Sebastian Berger, Dr. med.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

application of PEEP: starting PEEP = 15 mbar

Diagnostic Test

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)

application of PEEP: starting PEEP = 0 mbar

Diagnostic Test

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)

Primary outcomes

  1. Change in VExUS score at 0, 5,10 and 15 mbar during non-invasive ventilation (NIV) in the supine position.

    Time frame: up to 15 min

    The 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 outcomes

  1. Change in VExUS score at 0, 5,10,15 mbar during non-invasive ventilation in the prone position compared to the supine position.

    Time frame: up to 15 min

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregor Loosen, Dr. med.

CONTACT

[email protected]

+41 61 328 40 90

Kaspar Bachmann, PD Dr. med.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: VeNIVPro

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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