Hemodynamic MonitoringNCT03553667
Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
A study testing Standard group and ClearSight in people with Hemodynamic Monitoring and Perioperative Care, run by Chang Gung Memorial Hospital.
Trial summary
Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodynamic Monitoring, Perioperative Care, Outcome Assessment
- What is being tested?
- Standard group and ClearSight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2018to 31 Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia
- Subject agrees to participate the study
Who cannot join
- Age less than 18 years old
- Creatinine clearance < 30ml/min
- Vulnerable populations, including children, pregnant women, inmates, and persons with no capacity or with limited capacity
Trial locations and contacts
No sites are listed yet.
Johnson Chia-Shen Yang, M.D. contact
About this study
Official title: Perioperative Hemodynamic Optimization Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Hemodynamic monitors shows the benefits in perianesthetic care in fluid maintenance and decrease postanesthetic complication.
Invasive hemodynamic monitors, such as arterial line and FlowTrac, have risks of hematoma, infection, nerve injury in puncture site. In this study, photoplethysmography is applied comparing with conventional mean arterial pressure for perianesthetic hemodynamic optimization in bispectral index (BIS)-guided target-controlled infusion sedation on lymphatic venous anastomosis.
Read the detailed description
After allocation, patients would be assigned to Standard group or ClearSight group. All patients will be sedative with BIS-guided Propofol/Alfentanil Target-Controlled Infusion. The BIS will be maintained between 40-70 with electromyography(EMG) < 30%. Ce(effect site concentration) of Propofol is adjusted according to BIS score. Ce of Alfentanil is adjusted between 15-75 ng/ml. Patients have spontaneous respiration during the procedure with O2 simple mask. If the oxygen saturation by pulse oximetry(SpO2) < 95%, prescribe chin lift first. Nasopharyngeal airways is given if chin lift can not improve the saturation. Crystalloid, usually Lactate Ringer, is infused with the rate 4ml/kg/hr. The goal of Standard group is to maintain mean arterial pressure(MAP) > 60%. If MAP < 60%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed. ClearSight group is to maintain stroke volume(SV). If SV decreases more than 10%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed.
- Being tested
- Standard group, ClearSight
- Keywords
- Hemodynamic Monitoring, Perioperative Care, Outcome Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard groupDevice
Also called S group
Use radial arterial line to monitor mean arterial pressure
ClearSightDevice
Also called CS group
Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis Receives: Device: Standard group |
| ClearSight | Experimental | Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis Receives: Device: ClearSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal MAP fluctuation
In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum
Measured: after induction until recovery from anesthesia, assessed up to 24 hours
Maximal change of SVV
In ClearSight group, SVV(stroke volume variation measured from ClearSight), maximum minus minimum
Measured: after induction until recovery from anesthesia, assessed up to 24 hours
Secondary outcomes (4)
Urine output
urine output ml/kg/h
Measured: after induction until recovery from anesthesia, assessed up to 24 hours
Creatinine
Creatinine (serum)
Measured: preanesthesia and 24 hours postanesthesia
Acute kidney injury
use AKIN/RIFLE criteria
Measured: Loss of kidney function that develops within 7 days after surgery
Total fluid volume (ml)
In both groups, total crystalloid fluid volume used during anesthesia
Measured: after induction until recovery from anesthesia, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start10 Jun 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Chun Wu, M.D., Study chair, Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553667
- Sponsor's protocol ID
- 201701797B0
- Status last verified
- Dec 2017
- First submitted
- 7 May 2018
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hemodynamic Optimization Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
- ClinicalTrials.gov ID
- NCT03553667
- Acronym / sponsor ID
- 201701797B0
- Keywords
- Hemodynamic Monitoring, Perioperative Care, Outcome Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 10 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Jun 2018 (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.
Lymphatic venous anastomosis could be applied on patients suffering from limb lymphedema after surgery or radiotherapy. The particular pathophysiology leads unconventional fluid treatment strategy and changes in urine output. Hemodynamic monitors shows the benefits in perianesthetic care in fluid maintenance and decrease postanesthetic complication.
Invasive hemodynamic monitors, such as arterial line and FlowTrac, have risks of hematoma, infection, nerve injury in puncture site. In this study, photoplethysmography is applied comparing with conventional mean arterial pressure for perianesthetic hemodynamic optimization in bispectral index (BIS)-guided target-controlled infusion sedation on lymphatic venous anastomosis.
Detailed description
After allocation, patients would be assigned to Standard group or ClearSight group. All patients will be sedative with BIS-guided Propofol/Alfentanil Target-Controlled Infusion. The BIS will be maintained between 40-70 with electromyography(EMG) < 30%. Ce(effect site concentration) of Propofol is adjusted according to BIS score. Ce of Alfentanil is adjusted between 15-75 ng/ml. Patients have spontaneous respiration during the procedure with O2 simple mask. If the oxygen saturation by pulse oximetry(SpO2) < 95%, prescribe chin lift first. Nasopharyngeal airways is given if chin lift can not improve the saturation. Crystalloid, usually Lactate Ringer, is infused with the rate 4ml/kg/hr. The goal of Standard group is to maintain mean arterial pressure(MAP) > 60%. If MAP < 60%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed. ClearSight group is to maintain stroke volume(SV). If SV decreases more than 10%, 3ml/kg crystalloid is challenged in 10 minutes. If MAP still less than 60% after the second fluid challenge, Ephedrine 4-8mg iv is prescribed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Device: Standard groupAdult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis |
| ClearSight | Experimental | Device: ClearSightAdult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia
- Subject agrees to participate the study
Key exclusion criteria (3 listed)
- Age less than 18 years old
- Creatinine clearance < 30ml/min
- Vulnerable populations, including children, pregnant women, inmates, and persons with no capacity or with limited capacity
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 |
|---|---|---|
| Standard groupAlso: S groupUse radial arterial line to monitor mean arterial pressure | Device | Standard group |
| ClearSightAlso: CS groupUse Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume) | Device | ClearSight |
Primary outcome
Maximal MAP fluctuation
Time frame: after induction until recovery from anesthesia, assessed up to 24 hours
In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum
Maximal change of SVV
Time frame: after induction until recovery from anesthesia, assessed up to 24 hours
In ClearSight group, SVV(stroke volume variation measured from ClearSight), maximum minus minimum
4 secondary outcomes
Urine output
Time frame: after induction until recovery from anesthesia, assessed up to 24 hours
Creatinine
Time frame: preanesthesia and 24 hours postanesthesia
Acute kidney injury
Time frame: Loss of kidney function that develops within 7 days after surgery
Total fluid volume (ml)
Time frame: after induction until recovery from anesthesia, assessed up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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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.
Johnson Chia-Shen Yang, M.D. contact
Shao-Chun Wu, M.D. study chair
Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Standard group and ClearSight in people with Hemodynamic Monitoring and Perioperative Care, run by Chang Gung Memorial Hospital.
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 3 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Min-Hsien Chiang, M.D. (+886-7-7317123 ext. 2788, b9005035@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal MAP fluctuation (time frame: after induction until recovery from anesthesia, assessed up to 24 hours). The study lists 2 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 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.