Using the Edwards EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perioperative Hemodynamic Optimization Using the Edwards EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis

Conditions
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Perioperative Care, Hemodynamic Monitoring, Outcome Assessment

Intervention / Treatment
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* Device: Standard group
* Device: ClearSight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia Subject agrees to participate the study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard group<br>Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis | Device: Standard group<br>* Use radial arterial line to monitor mean arterial pressure<br>* Other names: S group;|
| Experimental: ClearSight<br>Adult patients, Creatinine clearance >= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis | Device: ClearSight<br>* Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)<br>* Other names: CS group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal MAP fluctuation | In standard group, MAP(mean arterial pressure measured from arterial line), maximum minus minimum | 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 | after induction until recovery from anesthesia, assessed up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine output | urine output ml/kg/h | after induction until recovery from anesthesia, assessed up to 24 hours | 
| Creatinine | Creatinine (serum) | preanesthesia and 24 hours postanesthesia | 
| Acute kidney injury | use AKIN/RIFLE criteria | 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 | after induction until recovery from anesthesia, assessed up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative Care, Hemodynamic Monitoring, Outcome Assessment