An interventional study of application of PEEP: starting PEEP = 15 mbar and application of PEEP: starting PEEP = 0 mbar in Venous Hemodynamics, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic
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.
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.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
First body position: randomized to supine position. Randomization of starting PEEP (0 or 15 mbar) in first body position and sequence of measurements. Second body position: Prone Position. Randomization of starting PEEP (0 or 15 mbar) in second body position and sequence of measurements.
Diagnostic Test: application of PEEP: starting PEEP = 15 mbar · Diagnostic Test: application of PEEP: starting PEEP = 0 mbar
First body position: randomized to prone position. Randomization of starting PEEP (0 or 15 mbar) in first body position and sequence of measurements. Second body position: Supine Position. Randomization of starting PEEP (0 or 15 mbar) in second body position and sequence of measurements.
Diagnostic Test: application of PEEP: starting PEEP = 15 mbar · Diagnostic Test: application 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 = 15 mbar: 5 min stepwise increase of PEEP Measurements with decremental PEEP (15, 10, 5, 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)
Change in VExUS score at 0, 5,10 and 15 mbar during non-invasive ventilation (NIV) in the supine position.
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.
Time frame: up to 15 min
Change in VExUS score at 0, 5,10,15 mbar during non-invasive ventilation in the prone position compared to the supine position.
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.
Time frame: up to 15 min
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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