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

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ClinicalTrials.gov Identifier: NCT03553667
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Hemodynamic Monitoring Perioperative Care Outcome Assessment Device: Standard group Device: ClearSight Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Hemodynamic Optimization Using the "Edwards" EV1000 Clinical Platform NI in Lymphatic Venous Anastomosis
Estimated Study Start Date : June 10, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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 Name: 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 Name: CS group




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Urine output [ Time Frame: after induction until recovery from anesthesia, assessed up to 24 hours ]
    urine output ml/kg/h

  2. Creatinine [ Time Frame: preanesthesia and 24 hours postanesthesia ]
    Creatinine (serum)

  3. Acute kidney injury [ Time Frame: Loss of kidney function that develops within 7 days after surgery ]
    use AKIN/RIFLE criteria

  4. Total fluid volume (ml) [ Time Frame: after induction until recovery from anesthesia, assessed up to 24 hours ]
    In both groups, total crystalloid fluid volume used during anesthesia


Other Outcome Measures:
  1. Fluid responsiveness [ Time Frame: after induction until recovery from anesthesia, assessed up to 24 hours ]
    After fluid challenge, MAP changes in Standard group or SV changes in ClearSight group

  2. Postoperative adverse events [ Time Frame: postoperative 30 days ]
    Including ileus, infection, and cardiovascular events

  3. Postoperative nausea and vomiting [ Time Frame: postoperative 24 hours ]
    Postoperative nausea and vomiting

  4. Recovery time [ Time Frame: From the stop of propofol infusion until full orientation of patient, up to 2 hours ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553667


Contacts
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Contact: Min-Hsien Chiang, M.D. +886-7-7317123 ext 2788 b9005035@cgmh.org.tw
Contact: Johnson Chia-Shen Yang, M.D. +886-7-7317123 ext 2788

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

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03553667     History of Changes
Other Study ID Numbers: 201701797B0
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: December 2017

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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
Keywords provided by Chang Gung Memorial Hospital:
Hemodynamic Monitoring
Perioperative Care
Outcome Assessment