SevofluraneNCT06707077
The Effect of Sevoflurane on Haemodynamics
An observational study of Sevoflurane and Cardiac Output, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Cardiac output (CO) is measured using Mostcare. Mean systemic filling pressure (MSFP) and vascular resistances are calculated using venous return curves constructed by measuring steady-state arterial and venous pressures and cardiac output (CO) during inspiratory hold manoeuvres at increasing plateau pressures. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Sevoflurane, Cardiac Output, Venous Return
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 5 Mar 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: The study enrolls patients 3-10 years, with American Association of Anesthesiologists (ASA) physical status score I-III, scheduled for major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring. Patients with symptomatic peripheral vascular disease or pulmonary disease, aberrant cardiovascular anatomy, significant valvular regurgitation, or severe arrhythmias are excluded.
Who may be able to join
- American Association of Anesthesiologists (ASA)physical status score I-III
- major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring.
Who cannot join
- symptomatic peripheral vascular disease or pulmonary disease
- aberrant cardiovascular anatomy
- significant valvular regurgitation
- severe arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sevoflurane on Cardiac Output, Mean Systemic Filling Pressure, and Vascular Resistances in Children
Cardiac output (CO) is measured using Mostcare. Mean systemic filling pressure (MSFP) and vascular resistances are calculated using venous return curves constructed by measuring steady-state arterial and venous pressures and cardiac output (CO) during inspiratory hold manoeuvres at increasing plateau pressures. Measurements are performed at three incremental levels of targeted sevoflurane concentrations.
Read the detailed description
Tracheal intubation is performed after anesthesia induction with sevoflurane. Radial arterial is cannulated and pressure transducer is connected to MostCare (core technique PRAM). HR, MAP, CVP, CO, SVR, PPV, and dp/dt are recorded at three incremental levels of targeted sevoflurane concentrations. MSFP and vascular resistances are calculated.
- Conditions
- Sevoflurane, Cardiac Output, Venous Return, Vascular Resistance
- Keywords
- sevoflurane, cardiac output, mean systemic filling pressure, vascular resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposure | The patient receives three increasing target end-tidal concentrations of sevoflurane, depending on what is hemodynamically (i.e. arterial hypotension) feasible in the individual patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output
Cardiac output is monitored using Mostcare via a radial arterial catheter connected to the pressure transducer.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
mean systemic filling pressure
Mean systemic filling pressure (MSFP) is calculated using venous return curve constructed by measuring steady-state arterial and venous pressures and CO during inspiratory hold manoeuvres at increasing plateau pressures. The CVP and CO data are fitted by linear regression to define the venous return curve. We define MSFP by extrapolation to zero flow.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
vascular resistance
Total systemic vascular resistance (Rsys) is calculated as the ratio of the pressure difference between mean Pa and mean CVP and CO. The resistance downstream to MSFP is taken to reflect the resistance to venous return (Rv) and is calculated as the ratio of the pressure difference between MSFP and CVP and CO. Systemic arterial resistance (Ra) is taken to be the difference between systemic and venous resistance.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Secondary outcomes (4)
mean arterial pressure
Systemic arterial blood pressure is monitored via a radial arterial catheter connected to a pressure transducer.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
central venous pressure
CVP is measured with a catheter inserted through the right internal jugular vein.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
pulse pressure variation
PPV is obtained from Mostcare.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
dP/dt
dP/dt is obtained from Mostcare.
Measured: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start5 Dec 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuan Wang, MD, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707077
- Sponsor's protocol ID
- HL-002-2024
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sevoflurane on Cardiac Output, Mean Systemic Filling Pressure, and Vascular Resistances in Children
- ClinicalTrials.gov ID
- NCT06707077
- Acronym / sponsor ID
- HL-002-2024
- Conditions
- Sevoflurane, Cardiac Output, Venous Return, Vascular Resistance
- Keywords
- sevoflurane, cardiac output, mean systemic filling pressure, vascular resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 27 Nov 2024 (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.
Cardiac output (CO) is measured using Mostcare. Mean systemic filling pressure (MSFP) and vascular resistances are calculated using venous return curves constructed by measuring steady-state arterial and venous pressures and cardiac output (CO) during inspiratory hold manoeuvres at increasing plateau pressures. Measurements are performed at three incremental levels of targeted sevoflurane concentrations.
Detailed description
Tracheal intubation is performed after anesthesia induction with sevoflurane. Radial arterial is cannulated and pressure transducer is connected to MostCare (core technique PRAM). HR, MAP, CVP, CO, SVR, PPV, and dp/dt are recorded at three incremental levels of targeted sevoflurane concentrations. MSFP and vascular resistances are calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure | – | –The patient receives three increasing target end-tidal concentrations of sevoflurane, depending on what is hemodynamically (i.e. arterial hypotension) feasible in the individual patient. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study enrolls patients 3-10 years, with American Association of Anesthesiologists (ASA) physical status score I-III, scheduled for major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring. Patients with symptomatic peripheral vascular disease or pulmonary disease, aberrant cardiovascular anatomy, significant valvular regurgitation, or severe arrhythmias are excluded.
Key inclusion criteria (2 listed)
- American Association of Anesthesiologists (ASA)physical status score I-III
- major elective surgery that dictates the use of invasive hemodynamic monitoring including CVP and continuous arterial blood pressure monitoring.
Key exclusion criteria (4 listed)
- symptomatic peripheral vascular disease or pulmonary disease
- aberrant cardiovascular anatomy
- significant valvular regurgitation
- severe arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cardiac output
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Cardiac output is monitored using Mostcare via a radial arterial catheter connected to the pressure transducer.
mean systemic filling pressure
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Mean systemic filling pressure (MSFP) is calculated using venous return curve constructed by measuring steady-state arterial and venous pressures and CO during inspiratory hold manoeuvres at increasing plateau pressures. The CVP and CO data are fitted by linear regression to define the venous return curve. We define MSFP by extrapolation to zero flow.
vascular resistance
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
Total systemic vascular resistance (Rsys) is calculated as the ratio of the pressure difference between mean Pa and mean CVP and CO. The resistance downstream to MSFP is taken to reflect the resistance to venous return (Rv) and is calculated as the ratio of the pressure difference between MSFP and CVP and CO. Systemic arterial resistance (Ra) is taken to be the difference between systemic and venous resistance.
4 secondary outcomes
mean arterial pressure
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
central venous pressure
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
pulse pressure variation
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
dP/dt
Time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.
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 12 Mar 2025.
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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.
Xuan Wang, MD study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sevoflurane and Cardiac Output, run by Children's Hospital of Fudan University at 1 site in China.
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 2 inclusion and 4 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 12 Mar 2025. 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 China. 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?
cardiac output (time frame: Hemodynamic parameters are recorded after 15 min of equilibration at each sevoflurane concentration.). The study lists 3 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 12 Mar 2025.