Hemodynamic Evaluation and Fluid Response Observation Through Respiratory Maneuvers

NCT07840040 | Completed

• 1 other identifier: HERO
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Responsiveness; Hemodynamics

Keywords

fluid responsiveness; non-invasive hemodynamic monitoring; respiratory maneuvers; stroke volume; spontaneous breathing

Outcome Measures

Primary Outcomes (8)

• Change in heart rate during respiratory manoeuvres

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

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

• Change in systolic arterial pressure during respiratory manoeuvres

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

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

• Change in mean arterial pressure during respiratory maneuvers

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

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

• Change in pulse pressure variation during respiratory manoeuvres

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

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

• Change in cardiac index during respiratory manoeuvres

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

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

• Change in stroke volume index during respiratory maneuvers

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

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

• Change in systemic vascular resistance index during respiratory maneuvers

  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.

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

• Change in stroke volume variation during respiratory manoeuvres

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

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

Study Arms (1)

Respiratory Maneuvers and Fluid Responsiveness Assessment

EXPERIMENTAL

Healthy volunteers undergo a hemodynamic assessment protocol consisting of four respiratory maneuvers, passive leg raising, and a fluid challenge, with continuous non-invasive hemodynamic monitoring.

Procedure: Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol

Interventions

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.

Respiratory Maneuvers and Fluid Responsiveness Assessment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers able to understand and perform the study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Pilsen: lead

Study Sites (1)

University Hospital Pilsen

Pilsen, Czech Republic, 323 00, Czechia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 24, 2026
• Study Start: October 22, 2024
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

CZ (1)