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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Non-French or non-German speakers

Unable to provide informed consent

Body mass index > 40kg/m

Self-reported pregnancy

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: 1. Supine position 2. Prone PositionExperimental treatment 2 interventions
Group B: 1. Prone Position 2. Supine PositionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.