The Effect of Fluid Management by SVV of FloTrac/ Vigileo™ Monitoring on Postoperative Recovery in Bowel Resection

September 12, 2017 updated by: Yonsei University
During an enterectomy, especially in an open surgery, large amounts of fluid are administered in consideration of the patient's fasted state, maintaining blood pressure during surgery and potential third space loss. However, it has recently been reported that excessive fluid administration during surgery is actually detrimental to patients' prognoses. In fact, several reports have suggested that compared to limited fluid administration, excessive fluid administration increased the length of stay or the chances of complications. Thus, goal-directed fluid optimization is required during surgery because only a proper amount of fluid (neither limited nor excessive) administration can minimize postoperative complications and enhance prognosis. In general, the amount of fluid administered is determined with regard to the patient's volume status, including a comprehensive assessment of vital signs such as the pulse rate and blood pressure, and urine volume. However, this method has limitations in that it is an inadequate indicator of the actual intravascular volume of a patient to determine and administer the proper amount of fluid. Recently, new methods of measuring volume status that are less invasive and more accurate have been introduced. These methods include stroke volume variation (SVV) that monitors changes in arterial pressure waveform amplitudes with regard to breathing patterns. This is an effective method of monitoring fluid responsiveness after placing a catheter via a radial artery puncture. The stroke output is dependent on the preload, afterload, and cardiac contractility. The cardiac output is determined by multiplying the stroke output and heart rate. SVV indicates the difference in stroke output within one breathing cycle. A direct or indirect measurement of stroke output is required, which can be performed by analyzing arterial pressure waveforms via a FloTrac Sensor (Edwards Lifesciences, USA) monitor. SVV is known to have a high fluid responsiveness even during open surgeries, yet there is practically no research data on its effect in patients' postoperative recovery and prognosis in comparison to the traditional methods of fluid administration. Therefore, the investigators will apply SVV via a FloTrac/ Vigileo™ monitor on patients undergoing bowel resection to determine whether it better assists proper fluid administration compared to the traditional method of fluid administration by examining the patients' postoperative prognosis such as bowel movement recovery and length of stay.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 20 to 70 scheduled to undergo bowel resection open surgery below the ASA class 3

Exclusion Criteria:

  • Patients with significant impairments in heart, kidney, and liver functions
  • Patients with arrhythmia such as tachycardia and atrial fibrillation or patients on pacemakers
  • Patients diagnosed with peripheral arterial disease or are Allen's test positive
  • Patients who underwent surgery on the identical surgical area
  • Patients with obesity
  • Patients with blood coagulation impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
For the traditional method group, crystalloid and colloid (maximum 50 ml/kg) are provided through the traditional method of assessing the blood pressure, heart rate and urine volume.
Device: Conventional arterial blood pressure monitoring
Experimental: SVV group
The method of fluid administration to be employed (traditional or SVV via a FloTrac/ EV1000™ monitor) is determined based on the group. Fluid administration is performed in accordance with the group; in general, about 10 ml/kg/h is administered although it may vary for each patient depending on the preoperative fasting, fluid loss during surgery (evaporation, emanation, urination, surgical area, etc.), and blood loss. Crystalloid is administered in the SVV-monitored group with a target below SVV 12%, and a 200-300 ml of colloid (maximum 50 ml/kg) is loaded when SVV is above 12%. If the patient shows hypertension even when SVV is below 12%, a vasoconstrictor should be administered intermittently or consistently.
Device: Stroke volume variation monitoring with arterial blood pressure monitoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery of bowel movement - gas passing time after bowel resection
Time Frame: 24 hous
To evaluate the difference in bowel movement recovery whether using SVV or not on the fluid management in the patients undergoing open enterectomy, the difference of postoperative gas passing time will be compared.
24 hous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2014-0730

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