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A Prospective Study Evaluating the Use of Intraoperative Stroke Volume Variation Via the FloTrac Device to Guide Fluid and Vasopressor Management in Head and Neck Free Flaps

NCT02186938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2018-09-20

Study results available
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Summary

This study aims to investigate whether the intraoperative use of the FloTrac device to guide fluid and vasopressor management during head and neck free flap surgery improves postoperative outcome. Primary postoperative outcome is length of hospital stay. Secondary postoperative outcomes include days in ICU, days on ventilator, presence of postoperative pulmonary edema, need for postoperative vasopressors or transfusions, 30 day flap complication rate, inpatient postoperative cardiorespiratory complications/events, and overall 30 day flap failure rate.

Conditions

Interventions

DEVICE

FloTrac

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Scott T Reeves, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186938 on ClinicalTrials.gov