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

Perioperative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03553667
• Other study ID #: 201701797B0
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2017
• Source: Chang Gung Memorial Hospital
• Contact: Min-Hsien Chiang, M.D.
• Phone: +886-7-7317123
• Email: b9005035[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Monitoring
• Outcome Assessment
• Perioperative Care

Intervention

Device:
• Standard group
Use radial arterial line to monitor mean arterial pressure
• ClearSight
Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Postoperative adverse events	Including ileus, infection, and cardiovascular events	postoperative 30 days
Other	Postoperative nausea and vomiting	Postoperative nausea and vomiting	postoperative 24 hours
Other	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
Primary	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
Primary	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	Urine output	urine output ml/kg/h	after induction until recovery from anesthesia, assessed up to 24 hours
Secondary	Creatinine	Creatinine (serum)	preanesthesia and 24 hours postanesthesia
Secondary	Acute kidney injury	use AKIN/RIFLE criteria	Loss of kidney function that develops within 7 days after surgery
Secondary	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