Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-10

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Hemodynamic Monitoring Perioperative Care Outcome Assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard group

Adult patients, Creatinine clearance \>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis

Group Type ACTIVE_COMPARATOR

Standard group

Intervention Type DEVICE

Use radial arterial line to monitor mean arterial pressure

ClearSight

Adult patients, Creatinine clearance \>= 30ml/min, with limb lymphedema, receiving lymphatic venous anastomosis

Group Type EXPERIMENTAL

ClearSight

Intervention Type DEVICE

Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)

Interventions

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Standard group

Use radial arterial line to monitor mean arterial pressure

Intervention Type DEVICE

ClearSight

Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)

Intervention Type DEVICE

Other Intervention Names

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S group CS group

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No