Stroke Volume VariationNCT06215157
A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness
A study testing Flotrac Group and BioZ Group in people with Stroke Volume Variation and SVV-FloTrac, run by RenJi Hospital at 1 site in China.
Trial summary
Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke Volume Variation, SVV-FloTrac, Thoracic Electrical Bioimpedance
- What is being tested?
- Flotrac Group and BioZ Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 30 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18≤ Age ≤65
- patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
- 18 kg/m2≤BMI≤30 kg/m2
- ASA classification I-III
- Patients signed informed consent form
Who cannot join
- Arrhythmias
- The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
- Severe heart failure (METS<4)
- The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
- The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
- There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
Show all 9Show fewer
- History of allergy to anesthetic drugs
- Weight<40kg
- Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiaotong University School of Medicine
Pudong, Shanghai Municipality, 200127
About this study
Official title: A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo
Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.
- Conditions
- Stroke Volume Variation, SVV-FloTrac, Thoracic Electrical Bioimpedance, Fluid Responsiveness
- Being tested
- Flotrac Group, BioZ Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotrac GroupDevice
Haemodynamic parameters were collected simultaneously by the Flotrac monitoring.
BioZ GroupDevice
Haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™)monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Flotrac Group | Active comparator | In this group,an arterial catheter was inserted preoperatively. An indwelling radial artery catheter was connected to the hemodynamic monitoring system (EV1000; Edward Lifesciences Corp., Irvine, CA, USA) via FloTrac™ (Edwards Lifesciences Corp.) sensors. Receives: Device: Flotrac Group |
| BioZ Group | Experimental | In this group,haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™) monitoring. Receives: Device: BioZ Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The capacity to predict fluid responsiveness.
After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the capacity to predict the fluid responsiveness of these two devices.
Measured: From anesthesia induction to the nonresponsive VLS about one hour.
Secondary outcomes (1)
The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the agreement of the two SVVs.
Measured: From anesthesia induction to the nonresponsive VLS about one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start30 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Volume VariationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215157
- Sponsor's protocol ID
- TEB-Zhoujie
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo
- ClinicalTrials.gov ID
- NCT06215157
- Acronym / sponsor ID
- TEB-Zhoujie
- Conditions
- Stroke Volume Variation, SVV-FloTrac, Thoracic Electrical Bioimpedance, Fluid Responsiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jan 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.
Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flotrac Group | Active comparator | Device: Flotrac GroupIn this group,an arterial catheter was inserted preoperatively. An indwelling radial artery catheter was connected to the hemodynamic monitoring system (EV1000; Edward Lifesciences Corp., Irvine, CA, USA) via FloTrac™ (Edwards Lifesciences Corp.) sensors. |
| BioZ Group | Experimental | Device: BioZ GroupIn this group,haemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™) monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18≤ Age ≤65
- patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
- 18 kg/m2≤BMI≤30 kg/m2
- ASA classification I-III
- Patients signed informed consent form
Key exclusion criteria (9 listed)
- Arrhythmias
- The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
- Severe heart failure (METS<4)
- The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
- The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
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 |
|---|---|---|
| Flotrac GroupHaemodynamic parameters were collected simultaneously by the Flotrac monitoring. | Device | Flotrac Group |
| BioZ GroupHaemodynamic parameters were collected simultaneously by the thoracic bioimpedance (BioZ.com™)monitoring. | Device | BioZ Group |
Primary outcome
The capacity to predict fluid responsiveness.
Time frame: From anesthesia induction to the nonresponsive VLS about one hour.
After anesthesia induction, volume loading was initiated. For each volume loading step (VLS), 100 mL of colloid solution (6% hydroxyethyl starch) was administered over a 2-minute duration. The SVV was measured and recorded simultaneously by FloTrac (SVV-FloTrac) and Transthoracic electrical bioimpedance(SVV-BioZ). Volume loading steps (VLS) continued until no responsive VLS was observed. Responsive VLS, defined as an increase in Flotrac-SV by at least 5%, and nonresponsive VLS, characterized by no change or an increase in Flotrac-SV by less than 5%, were subsequently identified. Multiple analysis methods were used to determine the capacity to predict the fluid responsiveness of these two devices.
1 secondary outcome
The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
Time frame: From anesthesia induction to the nonresponsive VLS about one hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flotrac Group and BioZ Group in people with Stroke Volume Variation and SVV-FloTrac, run by RenJi Hospital 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The capacity to predict fluid responsiveness. (time frame: From anesthesia induction to the nonresponsive VLS about one hour.). 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 22 Jan 2024.