Head and Neck CancerNCT02186938
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
A study testing FloTrac in people with Head and Neck Cancer and Patients Requiring a Free Flap Surgery, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Patients Requiring a Free Flap Surgery
- What is being tested?
- FloTrac
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Does the Intraoperative Use of the FloTrac Device to Guide Fluid and Vasopressor Management Affect Postoperative Morbidity in Patients Receiving a Head and Neck Microvascular Free Tissue Transfer
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.
Read the detailed description
Few animal models have shown that intravenous vasopressor administration (including use of pure alpha agonists such as phenylephrine) can decrease blood flow to free musculocutaneous flaps (1-3). This has led to a dogmatic belief that all vasopressors should be avoided intraoperatively during a microvascular free flap reconstruction regardless of patient hemodynamics, even though there is little published evidence that pressors negatively affect free flap outcome (4). As a result, these patients often receive generous amounts of fluids during their intraoperative course to combat periods of hypotension. However, patients receiving head and neck free tissue transfers tend to be older with serious comorbidities related to long term tobacco use such as significant cardiovascular and pulmonary disease. Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that may not necessarily be related to hypovolemia. Consistently treating periods of hypotension with more intravenous fluids can lead to serious postoperative complications such as graft failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a retrospective review of 248 patients over a 34 month period that received a head and neck free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid administration significantly increased 30 day flap complication rate while intraoperative administration of vasopressors did not affect 30 day flap complication or 30 day failure rate.
The FloTrac device is an approved and validated medical device that analyzes the arterial pressure waveform to calculate a stroke volume variation. This stroke volume variation can be used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor management during periods of intraoperative hypotension (5). The use of the FloTrac device for goal directed therapy has been investigated in major abdominal surgery and found to decrease length of hospital stay and complication rate in this surgical population (5-6). Thus, it is possible that the intraoperative use of the FloTrac device can better guide anesthesia providers to provide the necessary therapy for intraoperative hypotension in patients undergoing head and neck freet tissue transfer, thus improving postoperative outcome.
- Being tested
- FloTrac
- Keywords
- head and neck cancer, patients requiring a free flap surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloTracDevice
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: FloTrac |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Stay
The primary outcome is length of ICU stay.
Measured: Participants were assessed from entry into ICU until departure.
Secondary outcomes (1)
Number of Participants Requiring a Ventilator
The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator
Measured: The number of participants requiring a ventilator after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startDec 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott T Reeves, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186938
- Sponsor's protocol ID
- ENT FloTrac
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Intraoperative Use of the FloTrac Device to Guide Fluid and Vasopressor Management Affect Postoperative Morbidity in Patients Receiving a Head and Neck Microvascular Free Tissue Transfer
- ClinicalTrials.gov ID
- NCT02186938
- Acronym / sponsor ID
- ENT FloTrac
- Keywords
- head and neck cancer, patients requiring a free flap surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Few animal models have shown that intravenous vasopressor administration (including use of pure alpha agonists such as phenylephrine) can decrease blood flow to free musculocutaneous flaps (1-3). This has led to a dogmatic belief that all vasopressors should be avoided intraoperatively during a microvascular free flap reconstruction regardless of patient hemodynamics, even though there is little published evidence that pressors negatively affect free flap outcome (4). As a result, these patients often receive generous amounts of fluids during their intraoperative course to combat periods of hypotension. However, patients receiving head and neck free tissue transfers tend to be older with serious comorbidities related to long term tobacco use such as significant cardiovascular and pulmonary disease. Thus, they often exhibit intraoperative hemodynamic lability with periods of hypotension that may not necessarily be related to hypovolemia. Consistently treating periods of hypotension with more intravenous fluids can lead to serious postoperative complications such as graft failure (4), pulmonary edema, and congestive heart failure. In fact, we have just completed a retrospective review of 248 patients over a 34 month period that received a head and neck free tissue transfer; we discovered that a 1ml/kg/hr increase in intraoperative fluid administration significantly increased 30 day flap complication rate while intraoperative administration of vasopressors did not affect 30 day flap complication or 30 day failure rate.
The FloTrac device is an approved and validated medical device that analyzes the arterial pressure waveform to calculate a stroke volume variation. This stroke volume variation can be used to better guide intraoperative patient therapy with regard to need for fluid vs. pressor management during periods of intraoperative hypotension (5). The use of the FloTrac device for goal directed therapy has been investigated in major abdominal surgery and found to decrease length of hospital stay and complication rate in this surgical population (5-6). Thus, it is possible that the intraoperative use of the FloTrac device can better guide anesthesia providers to provide the necessary therapy for intraoperative hypotension in patients undergoing head and neck freet tissue transfer, thus improving postoperative outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: FloTracThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults requiring "free flap" tissue reassignment surgery for head and neck cancer at either MUSC or Vanderbilt Medical Center
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloTrac | Device | Treatment |
Primary outcome
ICU Stay
Time frame: Participants were assessed from entry into ICU until departure.
The primary outcome is length of ICU stay.
1 secondary outcome
Number of Participants Requiring a Ventilator
Time frame: The number of participants requiring a ventilator after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott T Reeves, MD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloTrac in people with Head and Neck Cancer and Patients Requiring a Free Flap Surgery, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Stay (time frame: Participants were assessed from entry into ICU until departure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.