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

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.

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Monitoring; Perioperative Care; Outcome Assessment
• Intervention / Treatment: Device: Standard group; Device: ClearSight

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min-Hsien Chiang, M.D.; Phone Number: 2788 +886-7-7317123; Email: b9005035@cgmh.org.tw
• Study Contact Backup: Name: Johnson Chia-Shen Yang, M.D.; Phone Number: 2788 +886-7-7317123

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid responsiveness	After fluid challenge, MAP changes in Standard group or SV changes in ClearSight group	after induction until recovery from anesthesia, assessed up to 24 hours
Postoperative adverse events	Including ileus, infection, and cardiovascular events	postoperative 30 days
Postoperative nausea and vomiting	Postoperative nausea and vomiting	postoperative 24 hours
Recovery time	From the stop of propofol infusion until full orientation of patient. Full orientation needs patients to be aware of where they are and who they are.	From the stop of propofol infusion until full orientation of patient, up to 2 hours

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Shao-Chun Wu, M.D., Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Perioperative Care; Outcome Assessment; Hemodynamic Monitoring
• Other Study ID Numbers: 201701797B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No