search
Back to results

Can Changes in Velocity Time Integral Serve as a Sensitive Indicator for Monitoring Changes in Stroke Volume ?

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Passive Leg Raising (PLR) test
Sponsored by
Fortis Hospital, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ischemic Heart Disease focused on measuring Doppler VTI TEE SV volume responsiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing CABG (coronary artery bypass surgery )

Exclusion Criteria:

  • Significant arrhythmias
  • Concomitant aortic aneurysms,
  • Esophageal pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    patients with LVEF >40%

    patients with LVEF < or equal to 40%

    Arm Description

    Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.

    Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.

    Outcomes

    Primary Outcome Measures

    Whether a change in Doppler VTI before and after passive leg raising test (PLR) correctly reflects changes in stroke volume measured by CCO PA catheter
    the 3 highest values of VTI post PLR measured between 30 seconds to maximum of 60 seconds post PLR test are to be used and their mean value is to be compared with the mean stroke volume (SV) recorded by the CCO monitor during the same period.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 13, 2014
    Last Updated
    November 17, 2014
    Sponsor
    Fortis Hospital, India
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02292888
    Brief Title
    Can Changes in Velocity Time Integral Serve as a Sensitive Indicator for Monitoring Changes in Stroke Volume ?
    Official Title
    Can Changes in LVOT VTI Before and After Passive Leg Raising (PLR) Test Serve as a Sensitive Indicator for Changes in SV and CO and Hence Volume Responsiveness ?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fortis Hospital, India

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ). The LVOT diameter for an individual is more or less a constant measurement. Therefore using the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this assumption is true, then an increase in the value of VTI from baseline after fluid challenge (10-15%), should identify a volume responsive patient.
    Detailed Description
    Can changes in LVOT VTI before and after passive leg raising (PLR) test serve as a sensitive indicator for changes in SV and CO and hence volume responsiveness ? What is Doppler LVOT VTI? Placing a Pulsed Wave Doppler gate on the LVOT immediately below the opening of the aortic valve while aligning the Doppler beam as parallel to the LVOT/aortic axis as possible with an angle of Doppler alignment <20˚, one may obtain Doppler flow velocity measurements which can help measure the LVOT VTI (Velocity Time Integral). If one integrates this velocity profile between two time points (i.e., calculates the area under the curve), the distance traversed of "a region of blood" flowing during this period may be estimated. Since flow velocity is not constant throughout a flow cycle, all of the flow velocities during the entire ejection period is integrated to measure "distance traversed" of this "region of blood." This integration of flow velocities in a given period of time is called the velocity-time integral (VTI)(1) and yields length or distance (measured in cm). Goal: Whether VTI (LVOT) measured from the deep transgastric (deep TG) or transgastric long axis (TG LAX ) views reflect changes in stroke volume(SV) and hence cardiac output (CO) measured by the gold standard method (PA CCO by thermodilution) before and after passive leg raising test (PLR). Hypothesis: A validated technique to measure cardiac output (CO) using echocardiography is to calculate stroke volume from the product of LVOT area and LVOT VTI and multiplying the product with heart rate ( CO = SV x H/R; SV = LVOT area x LVOT VTI ). The LVOT diameter for an individual is more or less a constant measurement. Therefore using the formula mentioned above (SV = LVOT area x LVOT VTI), if the LVOT area is constant, then SV should be proportional to the VTI. This means if a PLR manoeuvre or fluid bolus helps to achieve a rise in SV, then it should be reflected in an increase in VTI as well. If this assumption is true, then an increase in the value of VTI from baseline after fluid challenge (10-15%), should identify a volume responsive patient. Why do the investigators wish to do the study? A significant improvement in the field of anesthesiology would occur if we could have a simple yet accurate relatively non-invasive tool to correctly assess fluid responsiveness. Excessive fluid infused in the operating room would prolong mechanical ventilation and stay in the ICU and negatively affect the prognosis of the patient. While monitoring with CCO PA catheter considerable adds to the expense, it has its own complications and as may not be indicated in majority of operative cases. A simple non invasive tool using TEE can significantly add to our understanding of hemodynamics and help guide fluid therapy. If our assumption proves to be correct, then it could be a simple, yet rapid bedside indicator of CO. It could be used as a simple tool to assess fluid responsiveness. The fundamental reason why a fluid challenge (PLR or fluid boluses) is used is to assess whether there is an increase stroke volume in response to it (2). If the fluid loading fails to improve the stroke volume the fluid challenge/loading serves no useful purpose. In normal physiological conditions both the ventricles operate on the ascending limb of the Frank-Starling curve. Once the left ventricle starts functioning on the 'flat' portion of the Frank-Starling curve, fluid loading has little or no effect on stroke volume. If LVOT VTI could be shown to reflect SV adequately then it will be a relatively simple non invasive dynamic bedside tool to test if fluid boluses are resulting in an increase in VTI hence the SV. Volume responsiveness has been assessed in literature by measuring the response to fluid boluses or to PLR. Thus a positive test where after a PLR, VTI increased significantly reflecting a positive change in SV and CO, more fluid would be required. Whereas if during PLR, CO and SV diminished reflected by a decrease in the VTI value compared to baseline, the subject would be unlikely to respond to fluid therapy and probably would require inotropic support. Why PLR ? A recent meta-analysis (3), which pooled the results of eight recent studies, confirmed the excellent value of PLR to predict fluid responsiveness in critically ill patients with a global area under the receiver operating characteristic curve of 0.95. Limitations of using Doppler VTI: However, use of these equations entails a number of assumptions, including (a) laminar blood flow in the area interrogated, (b) a flat or blunt flow velocity profile such that the flow across the entire CSA interrogated is relatively uniform, and (c) Doppler angle of incidence between the Doppler beam and the main direction of blood flow is less than 20 degrees, so that the underestimation of the flow velocity is less than 6%. Study population: 50 adult patients undergoing coronary artery bypass surgery. Materials & Methods: After institutional ethics committee approval and personal informed consent, 50 patients undergoing elective coronary artery bypass surgery would be included into the study. Patients with significant arrhythmias, concomitant aortic aneurysms, and esophageal pathology precluding the use of TEE would be considered ineligible for the study. Patients would be divided into two groups. Patients with normal LV function or mild LV systolic dysfunction (LVEF >40%)(4), assessed by preoperative echocardiography would comprise Group 1, whereas those with preoperative LV moderate to severe systolic dysfunction (LVEF <40%)(4) would be designated to Group 2. Anesthetic protocol: Patients would be fasted for 8 hours preceding the operation. No i.v. fluids would be administered during this period. Patients would be pre-medicated with their usual cardiovascular medication and 1mg of Lorazepam the night before and would receive 1-2 mg of Midazolam at arrival to the operation theatre. After initiating standard monitoring (ECG, Pulse oximetry, NBP) invasive lines would be introduced under local anesthetic infiltration while the patient would receive supplemental oxygen via facemask. Induction of anesthesia would include 0.05 mg kg_1 Midazolam and 5 mcg kg_1 Fentanyl in addition to Sevoflurane 3-5% titrated to loss of eyelash reflex. Tracheal intubation would be facilitated by Rocuronium 0.1 mg kg_1. Anaesthesia would be maintained by Sevoflurane 1.5-2% titrated to an end tidal value of >1.5%and above supplemented by additional doses of fentanyl up to a total dose of 15-20 mg kg_1. All patients would receive 500 ml of lactated Ringer solution during the induction period. Hemodynamic and Echocardiographic monitoring. A 7.0Fr triple lumen central line, a 8.5 Fr PA sheath and 7.0 Fr CCO (Continuous Cardiac Output) PA catheter and a 16 G femoral arterial canula would be introduced prior to induction of anesthesia under light sedation and local anesthesia. ''''A Philips HD 11XE ultrasound machine (Andover, USA) and transesophageal multiplane echocardiographic probe would be used in all patients. After a comprehensive TEE examination the probe would be positioned to record images from either a deep TG or TGLAX views. Images would be recorded for off-line evaluation. A Board certified echocardiographer proficient in TEE would perform all echocardiographic measurements. Offline echocardiographic measurements would be done by a trained echocardiographer who would be blinded to the study protocol. All hemodynamic measurements will be recorded by a dedicated research nurse. Experimental protocol: After the induction of anesthesia and initiation of hemodynamic monitoring the patients would be stabilized as necessary and observed for 10-15 min. No further interventions would be allowed during this period, including further fluid administration, changes in anesthetic concentrations or manipulations with inotropic or vasoconstrictor concentrations. A period of at least 5 min of stable BP, heart rate, CVP, and continuous cardiac output would be required before obtaining the baseline set of hemodynamic measurements. A passive leg raising (PLR) maneuver (45%) using protocol described before* in literature would be performed and changes in hemodynamic and echocardiographic parameters would be measured within 1 minute post PLR. The same sequence of PLR and echocardiographic and hemodynamic measurements would be repeated after the end of the operation and before the transfer to the ICU. No measurements would be carried out in the presence of hemodynamic instability or immediately following changes of inotropic or anesthetic medications. The first set of measurements (HR, MAP, VTI, SV, CO, LVEF and LVOT area ) would be obtained in the semi-recumbent position (45°; designated 'baseline'). Then, the lower limbs would be lifted while straight (45°) with the trunk lowered in the supine position. The second set of measurements of (designated 'during PLR') was obtained during leg elevation, at the moment when VTI plateaued at its highest value. The stroke volume with CCO monitor would be recorded at the moment when it plateaued at its highest value. NB. Why record changes in VTI/SV etc . within 1 minute post PLR ? Because the maximal hemodynamic effects of PLR occur within the first minute of leg elevation, it is important to assess these effects with a method that is able to track changes in cardiac output or stroke volume on a real-time basis.(5) NB. Passive leg raising. The passive leg raising test consists in measuring the hemodynamic effects of a leg elevation up to 45°. A simple way to perform the postural maneuver is to transfer the patient from the semirecumbent posture to the passive leg raising position by using the automatic motion of the bed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Heart Disease
    Keywords
    Doppler VTI TEE SV volume responsiveness

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with LVEF >40%
    Arm Type
    Active Comparator
    Arm Description
    Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.
    Arm Title
    patients with LVEF < or equal to 40%
    Arm Type
    Active Comparator
    Arm Description
    Correlation between hemodynamic variable : SV and echocardiographic variable : Doppler VTI will be compared before and after Passive Leg Raising (PLR) test.
    Intervention Type
    Other
    Intervention Name(s)
    Passive Leg Raising (PLR) test
    Intervention Description
    Passive Leg Raising (PLR) test
    Primary Outcome Measure Information:
    Title
    Whether a change in Doppler VTI before and after passive leg raising test (PLR) correctly reflects changes in stroke volume measured by CCO PA catheter
    Description
    the 3 highest values of VTI post PLR measured between 30 seconds to maximum of 60 seconds post PLR test are to be used and their mean value is to be compared with the mean stroke volume (SV) recorded by the CCO monitor during the same period.
    Time Frame
    within 1 minute

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing CABG (coronary artery bypass surgery ) Exclusion Criteria: Significant arrhythmias Concomitant aortic aneurysms, Esophageal pathology

    12. IPD Sharing Statement

    Citations:
    Citation
    1. Reich DL Gregory W. Perioperative Transesophageal Echocardiography: A Companion to Kaplan's Cardiac Anesthesia by . Fischer 1st edition. Chapter 4.
    Results Reference
    background
    PubMed Identifier
    21906322
    Citation
    Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.
    Results Reference
    result
    PubMed Identifier
    20502865
    Citation
    Cavallaro F, Sandroni C, Marano C, La Torre G, Mannocci A, De Waure C, Bello G, Maviglia R, Antonelli M. Diagnostic accuracy of passive leg raising for prediction of fluid responsiveness in adults: systematic review and meta-analysis of clinical studies. Intensive Care Med. 2010 Sep;36(9):1475-83. doi: 10.1007/s00134-010-1929-y. Epub 2010 May 26.
    Results Reference
    result
    PubMed Identifier
    20394904
    Citation
    Atherton JJ. Screening for left ventricular systolic dysfunction: is imaging a solution? JACC Cardiovasc Imaging. 2010 Apr;3(4):421-8. doi: 10.1016/j.jcmg.2009.11.014.
    Results Reference
    result
    PubMed Identifier
    16540963
    Citation
    Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
    Results Reference
    result
    Links:
    URL
    https://www.inkling.com/read/reich-perioperative-transesophageal-echocardiography-1st/chapter-4/doppler-measurements-of-flow
    Description
    Citation 1: Reich DL Gregory W. Perioperative Transesophageal Echocardiography: A Companion to Kaplan's Cardiac Anesthesia by . Fischer 1st edition. Chapter 4.

    Learn more about this trial

    Can Changes in Velocity Time Integral Serve as a Sensitive Indicator for Monitoring Changes in Stroke Volume ?

    We'll reach out to this number within 24 hrs