<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02263664</url>
  </required_header>
  <id_info>
    <org_study_id>17551</org_study_id>
    <nct_id>NCT02263664</nct_id>
  </id_info>
  <brief_title>Observational Study of Sublingual Microcirculatory Blood Flow Characteristics in Patients Undergoing Transthoracic Esophagectomy</brief_title>
  <official_title>Observational Study of Sublingual Microcirculatory Blood Flow Characteristics in Patients Undergoing Transthoracic Esophagectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microcirculatory alterations occur in critically ill patients and those undergoing major&#xD;
      surgeries. The severity of perioperative microvascular alterations appear to be related to&#xD;
      the severity of organ dysfunction after surgery. Non-cardiac thoracic surgeries comprise a&#xD;
      subgroup of high risk surgical procedures which have the potential to significantly affect&#xD;
      and impair microcirculatory function but this patient population has not been well studied.&#xD;
      Esophagectomy surgery in particular produces a profound systemic inflammatory response which&#xD;
      correlates with a number of adverse outcomes. It is likely, though unproven, that&#xD;
      microcirculatory derangements may underly these phenomena. Though the study of&#xD;
      microcirculatory dysfunction in thoracic surgery is in its infancy, the body of available&#xD;
      evidence at this point supports the following hypotheses; that microcirculatory derangements&#xD;
      and dysfunction 1) occur during major surgeries including transthoracic esophagectomy 2) may&#xD;
      be related to SIRS, 3) may predict adverse outcomes, and 4) may be amenable to modification&#xD;
      via specific therapies.&#xD;
&#xD;
      We propose a prospective observational study to determine the effects of transthoracic&#xD;
      esophagectomy on microcirculatory function. Two hundred patients meeting inclusion criteria&#xD;
      undergoing planned transthoracic esophagectomy via thoracotomy incision will be prospectively&#xD;
      enrolled at The University of Virginia. Patients will be followed for 28 days or until&#xD;
      discharge from the ICU. Evaluation of the sublingual, gastric serosal and mucosal tissues&#xD;
      will be performed using sidestream dark field (SDF) imaging using the CytoCam® by Braedius&#xD;
      Medical BV (Huizen, The Netherlands). Scoring of the microcirculation will include an index&#xD;
      of vascular density (perfused vessel density), an assessment of capillary perfusion&#xD;
      (proportion of perfused vessels and microcirculatory flow index) and a heterogeneity index.&#xD;
&#xD;
      Note: the CytoCam® will only take a series of images as consistent with a microscope of&#xD;
      exposed tissue. Also, the FDA Office of Device Evaluations (ODE) General Surgery Devices&#xD;
      Branch One - Light Based/laser (GSDB1) has deemed this device to be exempt from 510(K)&#xD;
      approval.&#xD;
&#xD;
      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5021&#xD;
&#xD;
      Data from patient's medical charts before and after surgery (30 days post) will be used for&#xD;
      elucidation of specific complications. We will use the cardiovascular and respiratory&#xD;
      components of the SOFA score as independent measures of organ dysfunction. Acute kidney&#xD;
      injury will be defined by the AKIN criteria as an increase of at least 50% above baseline&#xD;
      serum creatinine and will be graded from stage 1 to 3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Provide the scientific background, rationale and relevance of this project. The&#xD;
      microcirculation plays a fundamental role in gas and nutrient exchange; it must constantly&#xD;
      adapt by controlling vascular tone and regional blood flow. In disease states, increased&#xD;
      permeability may be necessary to produce the inflammatory response. The assessment and&#xD;
      quantification of the macrovascular hemodynamics and the assumption that it is reflective of&#xD;
      microvascular change is fundamentally flawed. Even when global hemodynamic variables are&#xD;
      corrected, many patients with circulatory failure will develop multi organ failure and&#xD;
      ultimately die. The recent advent of in vivo microcirculation monitoring has begun to improve&#xD;
      our understanding of the relationships between surgery, anesthetic management, and regulation&#xD;
      of the microcirculation.&#xD;
&#xD;
      Microcirculatory alteration also occurs in patients undergoing cardiac surgery. Bauer et al&#xD;
      first reported that microcirculatory perfusion was transiently altered in humans after&#xD;
      cardiopulmonary bypass. Similar findings were reported more recently by other groups. , More&#xD;
      importantly, these alterations can also be observed in patients who undergo surgery without&#xD;
      cardiopulmonary bypass.3 Furthermore the sublingual microcirculation was still slightly&#xD;
      abnormal up to 24 h after surgery in these patients. As in non-cardiac surgery, the severity&#xD;
      of perioperative microvascular alterations correlated with peak lactate levels and severity&#xD;
      of organ dysfunction after surgery.iii High-risk surgery is a new area in which in vivo&#xD;
      microcirculatory alterations have been observed. In patients undergoing high-risk non-cardiac&#xD;
      surgery, Jhanji et al observed that the density and proportion of perfused capillaries was&#xD;
      lower in the 14 patients who subsequently developed postoperative complications than in the&#xD;
      11 patients with an uneventful postoperative course. Subcutaneous tissue PO2 and laser&#xD;
      Doppler cutaneous blood flow did not differ between the groups, further highlighting the lack&#xD;
      of sensitivity of these methods to detect heterogeneous perfusion. Interestingly, there was&#xD;
      no significant difference in global O2 delivery between the groups.&#xD;
&#xD;
      Non-cardiac thoracic surgeries comprise a subgroup of high risk surgical procedures which&#xD;
      have the potential to significantly affect and impair microcirculatory function. A study of&#xD;
      patients undergoing esophagectomy demonstrated significant impairment of sublingual&#xD;
      microcirculation relative to pancreaticoduodenectomy patients. Esophagectomy surgery produces&#xD;
      a profound systemic inflammatory response which correlates to a number of adverse outcomes.&#xD;
      Interestingly, the time course of microcirculatory impairment and recovery appears to&#xD;
      parallel the SIRS typically seen in surgeries of this type. Transthoracic esophagectomy is&#xD;
      typically facilitated by one lung ventilation (OLV) in an effort to optimize surgical&#xD;
      exposure to the operative hemithorax. The institution of OLV has the potential to&#xD;
      dramatically impair tissue oxygen supply demand relationships via adverse effects on systemic&#xD;
      oxygen desaturation, as a result of an increased venous admixture from right to left&#xD;
      intrapulmonary shunting, as well as decrements in cardiac output. Cerebral oxygen&#xD;
      desaturation accompanying OLV is also well described, though the pathophysiology is not well&#xD;
      understood. It is likely, though unproven, that microcirculatory derangements may underly&#xD;
      these phenomena. Though the study of microcirculatory dysfunction in thoracic surgery is in&#xD;
      its infancy, the body of available evidence at this point supports the following hypotheses;&#xD;
      that microcirculatory derangements and dysfunction 1) occur during major surgeries including&#xD;
      transthoracic esophagectomy 2) may be related to SIRS, OLV or both, 3) may predict adverse&#xD;
      outcomes, and 4) may be amenable to modification via specific therapies.&#xD;
&#xD;
      This is a feasibility study to see if the changes in microcirculatory parameters as observed&#xD;
      by the SDF device can accurately diagnose anastomotic and other complications for the purpose&#xD;
      of leading to a wider study of microcirculatory derangements as an indicator of risk of&#xD;
      surgical complications.&#xD;
&#xD;
      Hypothesis to be Tested:&#xD;
&#xD;
      i. Microcirculatory derangements, as indicated by changes in microcirculation of sublingual&#xD;
      tissue, serosa tunica near the surgical division, or the mucosal lining of the stomach near&#xD;
      the surgical division, occur during transthoracic esophagectomy and in the perioperative&#xD;
      period.&#xD;
&#xD;
      ii. Changes in microcirculation predicts post-operative anastomotic complications iii.&#xD;
      Changes in microcirculation predicts post-operative complications&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
        1. Determine whether microcirculatory derangements, as indicated by changes in&#xD;
           microcirculation of sublingual tissue, serosa tunica near the surgical division, or the&#xD;
           mucosal lining of the stomach near the surgical division, occur during transthoracic&#xD;
           esophagectomy involving one lung ventilation (OLV), using a side stream dark field (SDF)&#xD;
           imaging system.&#xD;
&#xD;
           1.1. This aim will include measurements of microcirculatory parameters at multiple time&#xD;
           points within the perioperative period.&#xD;
&#xD;
        2. Determine the temporal relationship of microcirculatory dysfunction and recovery, if&#xD;
           any, at the initiation of OLV, reestablishment of two lung ventilation, and cessation of&#xD;
           surgery.&#xD;
&#xD;
           2.1. This aim will include measurements of microcirculatory parameters at multiple time&#xD;
           points within the perioperative period.&#xD;
&#xD;
        3. Determine whether observed changes in microcirculation is predictive of postoperative&#xD;
           organ dysfunction, and perioperative complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Microcirculation parameters as observed with Sidestream Dark Field Microscopy an indicator of post operative complications</measure>
    <time_frame>3 YEARS</time_frame>
    <description>Is Microcirculation derangement in the mucosal bed an indicator of post-operative complications? Can we use the Sidestream Dark Field Microscopy to detect microcirculation derangements as a precursor to post operative complications?</description>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Transthoracic Esophagectomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Race: ANY&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 through 75 years&#xD;
&#xD;
          2. Subjects are undergoing transthoracic esophagectomy utilizing thoracotomy or&#xD;
             thoracoscopy incisions as part of their clinical care. These surgeries include&#xD;
             primarily the Ivor Lewis, and three hole (McKeown) esophagectomy procedures and&#xD;
             variants thereof.&#xD;
&#xD;
          3. A patent arterial line&#xD;
&#xD;
          4. A patent IV line&#xD;
&#xD;
          5. Must be able to read and speak English&#xD;
&#xD;
          6. Subjects may have current diagnosis of cancer that requires esophagectomy as part of&#xD;
             their clinical care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects unable/unwilling to give informed consent.&#xD;
&#xD;
          2. Cognitively Impaired&#xD;
&#xD;
          3. Prisoners&#xD;
&#xD;
          4. Pregnant females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RANDAL BLANK, M.D. PH.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MARCIA E BIRK</last_name>
    <phone>434-982-0230</phone>
    <email>MEB2W@VIRGINIA.EDU</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>KEITA IKEDA, PHD</last_name>
    <phone>9195931174</phone>
    <email>KEITA@VIRGINIA.EDU</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22910-0710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MARCIA E BIRK</last_name>
      <phone>434-982-0230</phone>
      <email>meb2w@virginia.edu</email>
    </contact>
    <contact_backup>
      <last_name>KEITA IKEDA, PHD</last_name>
      <phone>919-593-1174</phone>
      <email>KEITA.IKEDA@VIRGINIA.EDU</email>
    </contact_backup>
    <investigator>
      <last_name>BHIKEN NAIK, M.B.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bauer A, Kofler S, Thiel M, Eifert S, Christ F. Monitoring of the sublingual microcirculation in cardiac surgery using orthogonal polarization spectral imaging: preliminary results. Anesthesiology. 2007 Dec;107(6):939-45. doi: 10.1097/01.anes.0000291442.69337.c9.</citation>
    <PMID>18043062</PMID>
  </reference>
  <reference>
    <citation>Atasever B, Boer C, Goedhart P, Biervliet J, Seyffert J, Speekenbrink R, Schwarte L, de Mol B, Ince C. Distinct alterations in sublingual microcirculatory blood flow and hemoglobin oxygenation in on-pump and off-pump coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):784-90. doi: 10.1053/j.jvca.2010.09.002. Epub 2010 Nov 5.</citation>
    <PMID>21115363</PMID>
  </reference>
  <reference>
    <citation>Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.</citation>
    <PMID>24161555</PMID>
  </reference>
  <reference>
    <citation>Jhanji S, Lee C, Watson D, Hinds C, Pearse RM. Microvascular flow and tissue oxygenation after major abdominal surgery: association with post-operative complications. Intensive Care Med. 2009 Apr;35(4):671-7. doi: 10.1007/s00134-008-1325-z. Epub 2008 Oct 21.</citation>
    <PMID>18936911</PMID>
  </reference>
  <reference>
    <citation>van Genderen M, Gommers D, Klijn E, Lima A, Bakker J, van Bommel J. Postoperative sublingual microcirculatory derangement following esophagectomy is prevented with dobutamine. Clin Hemorheol Microcirc. 2011;48(4):275-83. doi: 10.3233/CH-2011-1421.</citation>
    <PMID>22012833</PMID>
  </reference>
  <reference>
    <citation>Wright CD, Kucharczuk JC, O'Brien SM, Grab JD, Allen MS; Society of Thoracic Surgeons General Thoracic Surgery Database. Predictors of major morbidity and mortality after esophagectomy for esophageal cancer: a Society of Thoracic Surgeons General Thoracic Surgery Database risk adjustment model. J Thorac Cardiovasc Surg. 2009 Mar;137(3):587-95; discussion 596. doi: 10.1016/j.jtcvs.2008.11.042. Erratum In: J Thorac Cardiovasc Surg. 2009 Jun;137(6):1581.</citation>
    <PMID>19258071</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>June 21, 2015</last_update_submitted>
  <last_update_submitted_qc>June 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Randal Blank, MD</investigator_full_name>
    <investigator_title>Associate Professor, Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>microcirculation</keyword>
  <keyword>esophagectomy</keyword>
  <keyword>side stream dark field</keyword>
  <keyword>microcirculatory derangements</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02263664
org study id: 17551
nct id: NCT02263664
lead sponsor: 
has dmc: No
Microcirculatory alterations occur in critically ill patients and those undergoing major
      surgeries. The severity of perioperative microvascular alterations appear to be related to
      the severity of organ dysfunction after surgery. Non-cardiac thoracic surgeries comprise a
      subgroup of high risk surgical procedures which have the potential to significantly affect
      and impair microcirculatory function but this patient population has not been well studied.
      Esophagectomy surgery in particular produces a profound systemic inflammatory response which
      correlates with a number of adverse outcomes. It is likely, though unproven, that
      microcirculatory derangements may underly these phenomena. Though the study of
      microcirculatory dysfunction in thoracic surgery is in its infancy, the body of available
      evidence at this point supports the following hypotheses; that microcirculatory derangements
      and dysfunction 1) occur during major surgeries including transthoracic esophagectomy 2) may
      be related to SIRS, 3) may predict adverse outcomes, and 4) may be amenable to modification
      via specific therapies.

      We propose a prospective observational study to determine the effects of transthoracic
      esophagectomy on microcirculatory function. Two hundred patients meeting inclusion criteria
      undergoing planned transthoracic esophagectomy via thoracotomy incision will be prospectively
      enrolled at The University of Virginia. Patients will be followed for 28 days or until
      discharge from the ICU. Evaluation of the sublingual, gastric serosal and mucosal tissues
      will be performed using sidestream dark field (SDF) imaging using the CytoCam® by Braedius
      Medical BV (Huizen, The Netherlands). Scoring of the microcirculation will include an index
      of vascular density (perfused vessel density), an assessment of capillary perfusion
      (proportion of perfused vessels and microcirculatory flow index) and a heterogeneity index.

      Note: the CytoCam® will only take a series of images as consistent with a microscope of
      exposed tissue. Also, the FDA Office of Device Evaluations (ODE) General Surgery Devices
      Branch One - Light Based/laser (GSDB1) has deemed this device to be exempt from 510(K)
      approval.

      http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5021

      Data from patient's medical charts before and after surgery (30 days post) will be used for
      elucidation of specific complications. We will use the cardiovascular and respiratory
      components of the SOFA score as independent measures of organ dysfunction. Acute kidney
      injury will be defined by the AKIN criteria as an increase of at least 50% above baseline
      serum creatinine and will be graded from stage 1 to 3.
1. Provide the scientific background, rationale and relevance of this project. The
      microcirculation plays a fundamental role in gas and nutrient exchange; it must constantly
      adapt by controlling vascular tone and regional blood flow. In disease states, increased
      permeability may be necessary to produce the inflammatory response. The assessment and
      quantification of the macrovascular hemodynamics and the assumption that it is reflective of
      microvascular change is fundamentally flawed. Even when global hemodynamic variables are
      corrected, many patients with circulatory failure will develop multi organ failure and
      ultimately die. The recent advent of in vivo microcirculation monitoring has begun to improve
      our understanding of the relationships between surgery, anesthetic management, and regulation
      of the microcirculation.

      Microcirculatory alteration also occurs in patients undergoing cardiac surgery. Bauer et al
      first reported that microcirculatory perfusion was transiently altered in humans after
      cardiopulmonary bypass. Similar findings were reported more recently by other groups. , More
      importantly, these alterations can also be observed in patients who undergo surgery without
      cardiopulmonary bypass.3 Furthermore the sublingual microcirculation was still slightly
      abnormal up to 24 h after surgery in these patients. As in non-cardiac surgery, the severity
      of perioperative microvascular alterations correlated with peak lactate levels and severity
      of organ dysfunction after surgery.iii High-risk surgery is a new area in which in vivo
      microcirculatory alterations have been observed. In patients undergoing high-risk non-cardiac
      surgery, Jhanji et al observed that the density and proportion of perfused capillaries was
      lower in the 14 patients who subsequently developed postoperative complications than in the
      11 patients with an uneventful postoperative course. Subcutaneous tissue PO2 and laser
      Doppler cutaneous blood flow did not differ between the groups, further highlighting the lack
      of sensitivity of these methods to detect heterogeneous perfusion. Interestingly, there was
      no significant difference in global O2 delivery between the groups.

      Non-cardiac thoracic surgeries comprise a subgroup of high risk surgical procedures which
      have the potential to significantly affect and impair microcirculatory function. A study of
      patients undergoing esophagectomy demonstrated significant impairment of sublingual
      microcirculation relative to pancreaticoduodenectomy patients. Esophagectomy surgery produces
      a profound systemic inflammatory response which correlates to a number of adverse outcomes.
      Interestingly, the time course of microcirculatory impairment and recovery appears to
      parallel the SIRS typically seen in surgeries of this type. Transthoracic esophagectomy is
      typically facilitated by one lung ventilation (OLV) in an effort to optimize surgical
      exposure to the operative hemithorax. The institution of OLV has the potential to
      dramatically impair tissue oxygen supply demand relationships via adverse effects on systemic
      oxygen desaturation, as a result of an increased venous admixture from right to left
      intrapulmonary shunting, as well as decrements in cardiac output. Cerebral oxygen
      desaturation accompanying OLV is also well described, though the pathophysiology is not well
      understood. It is likely, though unproven, that microcirculatory derangements may underly
      these phenomena. Though the study of microcirculatory dysfunction in thoracic surgery is in
      its infancy, the body of available evidence at this point supports the following hypotheses;
      that microcirculatory derangements and dysfunction 1) occur during major surgeries including
      transthoracic esophagectomy 2) may be related to SIRS, OLV or both, 3) may predict adverse
      outcomes, and 4) may be amenable to modification via specific therapies.

      This is a feasibility study to see if the changes in microcirculatory parameters as observed
      by the SDF device can accurately diagnose anastomotic and other complications for the purpose
      of leading to a wider study of microcirculatory derangements as an indicator of risk of
      surgical complications.

      Hypothesis to be Tested:

      i. Microcirculatory derangements, as indicated by changes in microcirculation of sublingual
      tissue, serosa tunica near the surgical division, or the mucosal lining of the stomach near
      the surgical division, occur during transthoracic esophagectomy and in the perioperative
      period.

      ii. Changes in microcirculation predicts post-operative anastomotic complications iii.
      Changes in microcirculation predicts post-operative complications

      Specific Aims

        1. Determine whether microcirculatory derangements, as indicated by changes in
           microcirculation of sublingual tissue, serosa tunica near the surgical division, or the
           mucosal lining of the stomach near the surgical division, occur during transthoracic
           esophagectomy involving one lung ventilation (OLV), using a side stream dark field (SDF)
           imaging system.

           1.1. This aim will include measurements of microcirculatory parameters at multiple time
           points within the perioperative period.

        2. Determine the temporal relationship of microcirculatory dysfunction and recovery, if
           any, at the initiation of OLV, reestablishment of two lung ventilation, and cessation of
           surgery.

           2.1. This aim will include measurements of microcirculatory parameters at multiple time
           points within the perioperative period.

        3. Determine whether observed changes in microcirculation is predictive of postoperative
           organ dysfunction, and perioperative complications.
time perspective: Prospective
measure: Microcirculation parameters as observed with Sidestream Dark Field Microscopy an indicator of post operative complications
time frame: 3 YEARS
description: Is Microcirculation derangement in the mucosal bed an indicator of post-operative complications? Can we use the Sidestream Dark Field Microscopy to detect microcirculation derangements as a precursor to post operative complications?
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: RANDAL BLANK, M.D. PH.D
role: Principal Investigator
affiliation: University of Virginia
last name: MARCIA E BIRK
phone: 434-982-0230
email: MEB2W@VIRGINIA.EDU
last name: KEITA IKEDA, PHD
phone: 9195931174
email: KEITA@VIRGINIA.EDU
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Bauer A, Kofler S, Thiel M, Eifert S, Christ F. Monitoring of the sublingual microcirculation in cardiac surgery using orthogonal polarization spectral imaging: preliminary results. Anesthesiology. 2007 Dec;107(6):939-45. doi: 10.1097/01.anes.0000291442.69337.c9.
PMID: 18043062
citation: Atasever B, Boer C, Goedhart P, Biervliet J, Seyffert J, Speekenbrink R, Schwarte L, de Mol B, Ince C. Distinct alterations in sublingual microcirculatory blood flow and hemoglobin oxygenation in on-pump and off-pump coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):784-90. doi: 10.1053/j.jvca.2010.09.002. Epub 2010 Nov 5.
PMID: 21115363
citation: Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
PMID: 24161555
citation: Jhanji S, Lee C, Watson D, Hinds C, Pearse RM. Microvascular flow and tissue oxygenation after major abdominal surgery: association with post-operative complications. Intensive Care Med. 2009 Apr;35(4):671-7. doi: 10.1007/s00134-008-1325-z. Epub 2008 Oct 21.
PMID: 18936911
citation: van Genderen M, Gommers D, Klijn E, Lima A, Bakker J, van Bommel J. Postoperative sublingual microcirculatory derangement following esophagectomy is prevented with dobutamine. Clin Hemorheol Microcirc. 2011;48(4):275-83. doi: 10.3233/CH-2011-1421.
PMID: 22012833
citation: Wright CD, Kucharczuk JC, O'Brien SM, Grab JD, Allen MS; Society of Thoracic Surgeons General Thoracic Surgery Database. Predictors of major morbidity and mortality after esophagectomy for esophageal cancer: a Society of Thoracic Surgeons General Thoracic Surgery Database risk adjustment model. J Thorac Cardiovasc Surg. 2009 Mar;137(3):587-95; discussion 596. doi: 10.1016/j.jtcvs.2008.11.042. Erratum In: J Thorac Cardiovasc Surg. 2009 Jun;137(6):1581.
PMID: 19258071
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Randal Blank, MD
investigator title: Associate Professor, Anesthesiology