NCT03553667

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 12, 2018

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

May 7, 2018

Last Update Submit

May 30, 2018

Conditions

Hemodynamic MonitoringPerioperative CareOutcome Assessment

Keywords

Hemodynamic MonitoringPerioperative CareOutcome Assessment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Urine output

    after induction until recovery from anesthesia, assessed up to 24 hours

  • Creatinine

    preanesthesia and 24 hours postanesthesia

  • Acute kidney injury

    Loss of kidney function that develops within 7 days after surgery

  • Total fluid volume (ml)

    after induction until recovery from anesthesia, assessed up to 24 hours

Other Outcomes (4)

  • Fluid responsiveness

    after induction until recovery from anesthesia, assessed up to 24 hours

  • Postoperative adverse events

    postoperative 30 days

  • Postoperative nausea and vomiting

    postoperative 24 hours

  • +1 more other outcomes

Study Arms (2)

Standard group

ACTIVE COMPARATOR

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

Device: Standard group

ClearSight

EXPERIMENTAL

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

Device: ClearSight

Interventions

Standard groupDEVICE

Use radial arterial line to monitor mean arterial pressure

Also known as: S group
Standard group
ClearSightDEVICE

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

Also known as: CS group
ClearSight

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject receiving lymphatic venous anastomosis operation with Bispectral-guided Propofol and Alfentanil target-controlled anesthesia
  • Subject agrees to participate the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Shao-Chun Wu, M.D.

    Department of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine

    STUDY CHAIR

Central Study Contacts

Min-Hsien Chiang, M.D.

CONTACT

+886-7-7317123b9005035@cgmh.org.tw

Johnson Chia-Shen Yang, M.D.

CONTACT

+886-7-7317123

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 12, 2018

Study Start

June 10, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

June 12, 2018

Record last verified: 2017-12