Effects of Positive End-Expiratory Pressure (PEEP) and Prone Positioning in Healthy Volunteers on Venous Hemodynamics Including the Venous Excess Ultrasound (VExUS) Score
NCT ID: NCT07273617
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-25
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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1. Supine position 2. Prone Position
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.
application 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)
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 = 0 mbar: Measurement with increasing PEEP (0, 5, 10, 15 mbar)
1. Prone Position 2. Supine Position
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.
application 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)
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 = 0 mbar: Measurement with increasing PEEP (0, 5, 10, 15 mbar)
Interventions
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application 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)
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 = 0 mbar: Measurement with increasing PEEP (0, 5, 10, 15 mbar)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to provide informed consent
* Body mass index \> 40kg/m
* Self-reported pregnancy
* History of pneumothorax
* Previously participated in the study
18 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Gregor Loosen, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Intensive Care Unit
Locations
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University Hospital Basel, Intensive Care Unit
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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am25Loosen2; 2025-01745
Identifier Type: -
Identifier Source: org_study_id
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