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NCT Number: NCT07840040

Hemodynamic Evaluation and Fluid Response Observation Through Respiratory Maneuvers

This study evaluates whether respiratory maneuvers can induce measurable hemodynamic changes and whether these changes may be used to assess fluid responsiveness in healthy volunteers. Hemodynamic parameters are continuously monitored non-invasively during four respiratory maneuvers, passive leg raising, and a fluid challenge. The hemodynamic responses to individual respiratory maneuvers are compared with the response to fluid administration.

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Key information

Conditions

Fluid Responsiveness Hemodynamics

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Pilsen

Pilsen, Czech Republic, 323 00, Czechia

About this study

Fluid responsiveness is commonly assessed using dynamic tests that transiently modify cardiac preload. In spontaneously breathing patients, however, assessment of fluid responsiveness remains challenging because many established dynamic indices rely on controlled mechanical ventilation. This proof-of-concept physiological study investigates whether respiratory maneuvers performed during spontaneous breathing induce measurable hemodynamic changes that could potentially be used for the assessment of fluid responsiveness. Healthy volunteers undergo four respiratory maneuvers: maximal inspiration followed by breath-hold, maximal expiration followed by breath-hold, Valsalva maneuver, and Müller maneuver. Hemodynamic variables are continuously monitored non-invasively. The hemodynamic responses to the respiratory maneuvers are evaluated in relation to passive leg raising and a subsequent fluid challenge.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers able to understand and perform the study procedures

Exclusion criteria

  • Age <18 years
  • History of cardiac arrhythmia, coronary artery disease, or valvular heart disease
  • Bronchial asthma or other respiratory disease associated with reduced vital capacity
  • History of increased intraocular pressure, including glaucoma, retinopathy, or intraocular implants
  • Inability to cooperate with the study procedures

Treatment and study plan

Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol

Procedure

Participants perform four respiratory maneuvers: maximal inspiration followed by breath-hold (M1), maximal expiration followed by breath-hold (M2), Valsalva maneuver (M3), and Müller maneuver (M4). Each respiratory maneuver lasts 20 seconds. The respiratory maneuvers are followed by passive leg raising and a fluid challenge consisting of 500 mL of balanced crystalloid administered intravenously over 10 minutes. Hemodynamic variables are continuously monitored non-invasively throughout the protocol.

Primary outcomes

  1. Change in heart rate during respiratory manoeuvres

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in heart rate (HR), measured in beats per minute (bpm), during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  2. Change in systolic arterial pressure during respiratory manoeuvres

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in systolic arterial pressure (SAP), measured in mmHg, during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  3. Change in mean arterial pressure during respiratory maneuvers

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in mean arterial pressure (MAP), measured in mmHg, during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  4. Change in pulse pressure variation during respiratory manoeuvres

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in pulse pressure variation (PPV), measured as a percentage (%), during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  5. Change in cardiac index during respiratory manoeuvres

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in cardiac index (CI), measured in L/min/m², during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  6. Change in stroke volume index during respiratory maneuvers

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in stroke volume index (SVI), measured in mL/m², during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  7. Change in systemic vascular resistance index during respiratory maneuvers

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in systemic vascular resistance index (SVRI), measured in dyn·s·cm-⁵·m², during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

  8. Change in stroke volume variation during respiratory manoeuvres

    Time frame: During each 20-second respiratory maneuver, within a single study visit.

    Change in stroke volume variation (SVV), measured as a percentage (%), during each of four respiratory maneuvers using continuous non-invasive hemodynamic monitoring.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital Pilsen

Other

Registry information

Acronym: HERO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

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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