Fluid ResponsivenessHERONCT07840040
Hemodynamic Evaluation and Fluid Response Observation Through Respiratory Maneuvers
A study testing Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol in people with Fluid Responsiveness and Hemodynamics, run by University Hospital Pilsen at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Responsiveness, Hemodynamics
- What is being tested?
- Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Oct 2024to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers able to understand and perform the study procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Fluid Responsiveness, Hemodynamics
- Being tested
- Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol
- Keywords
- fluid responsiveness, non-invasive hemodynamic monitoring, respiratory maneuvers, stroke volume, spontaneous breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Maneuvers and Fluid Responsiveness Assessment ProtocolProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During each 20-second respiratory maneuver, within a single study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start22 Oct 2024
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Pilsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840040
- Sponsor's protocol ID
- HERO
- Acronym
- HERO
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Evaluation and Fluid Response Observation Through Respiratory Maneuvers
- ClinicalTrials.gov ID
- NCT07840040
- Acronym / sponsor ID
- HERO / HERO
- Conditions
- Fluid Responsiveness, Hemodynamics
- Keywords
- fluid responsiveness, non-invasive hemodynamic monitoring, respiratory maneuvers, stroke volume, spontaneous breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital PilsenUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Maneuvers and Fluid Responsiveness Assessment | Experimental | Procedure: Respiratory Maneuvers and Fluid Responsiveness Assessment ProtocolHealthy volunteers undergo a hemodynamic assessment protocol consisting of four respiratory maneuvers, passive leg raising, and a fluid challenge, with continuous non-invasive hemodynamic monitoring. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers able to understand and perform the study procedures
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Maneuvers and Fluid Responsiveness Assessment ProtocolParticipants 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. | Procedure or surgery | Respiratory Maneuvers and Fluid Responsiveness Assessment |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Maneuvers and Fluid Responsiveness Assessment Protocol in people with Fluid Responsiveness and Hemodynamics, run by University Hospital Pilsen at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate during respiratory manoeuvres (time frame: During each 20-second respiratory maneuver, within a single study visit.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.