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 | Completed Results DMC

• 1 other identifier: ENT FloTrac
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Cancer; Patients Requiring a Free Flap Surgery

Keywords

head and neck cancer; patients requiring a free flap surgery

Outcome Measures

Primary Outcomes (1)

• ICU Stay

  The primary outcome is length of ICU stay.

  Participants were assessed from entry into ICU until departure.

Secondary Outcomes (1)

• Number of Participants Requiring a Ventilator

  The number of participants requiring a ventilator after surgery.

Study Arms (2)

Usual Care

NO INTERVENTION

Arterial line (radial, femoral, dorsalis pedis, or brachial), central line for access when needed, intubation vs tracheostomy, general anesthesia. We currently use stroke-volume variability monitoring (FloTrac) in all patients using the arterial line placed for blood pressure monitoring.

Treatment

EXPERIMENTAL

The study will use a treatment algorithm for patients in the treatment group. This algorithm will aim to maintain a near-normal blood pressure and use goal directed therapy to achieve this. Currently the standard of care is to use IV fluid exclusively in these patients and anesthesia providers everywhere have been challenging that treatment plan. Our algorithm has an iterative approach assessing volume status, cardiac output and vascular tone in order, with interventions specified for each. Individual treatments have been proven safe and effective in this population, we believe this sequence may be the best current management system. By avoiding excessive fluid administration we expect to decrease ICU length of stay due to the comorbidities caused (pulmonary edema, bowl edema, glycocalyx damage).

Device: FloTrac

Interventions

FloTrac DEVICE

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center

You may not qualify if:

• Patients \< 55kg or \> 140 kg based on literature regarding accuracy of flotrac.
• Patients with sustained intraoperative dysrrhythmias based on literature regarding accuracy of flotrac (ie, atrial flutter, atrial fibrillation).
• Patients with diagnosed NYHA class III-IV failure or documented EF \< 30%
• Patients with pulmonary disease preventing administration of goal tidal volumes without excessive inspiratory pressures.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr Hand
• Organization: MUSC

handw@musc.edu

843-792-5442

Study Officials

• Scott T Reeves, MD

  Medical University of South Carolina

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: July 10, 2014
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 20, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-08

Locations

US (1)