Observational Study of Sublingual Microcirculatory Blood Flow Characteristics in Patients Undergoing Transthoracic Esophagectomy

NCT02263664 | Unknown

• 1 other identifier: 17551
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transthoracic Esophagectomy

Keywords

microcirculation; esophagectomy; side stream dark field; microcirculatory derangements

Outcome Measures

Primary Outcomes (1)

• Microcirculation parameters as observed with Sidestream Dark Field Microscopy an indicator of post operative complications

  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?

  3 YEARS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Race: ANY

You may qualify if:

• Age 18 through 75 years
• Subjects are undergoing transthoracic esophagectomy utilizing thoracotomy or thoracoscopy incisions as part of their clinical care. These surgeries include primarily the Ivor Lewis, and three hole (McKeown) esophagectomy procedures and variants thereof.
• A patent arterial line
• A patent IV line
• Must be able to read and speak English
• Subjects may have current diagnosis of cancer that requires esophagectomy as part of their clinical care.

You may not qualify if:

• Subjects unable/unwilling to give informed consent.
• Cognitively Impaired
• Prisoners
• Pregnant females

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22910-0710, United States

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19258071 BACKGROUND

Study Officials

• RANDAL BLANK, M.D. PH.D

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARCIA E BIRK

CONTACT

434-982-0230; MEB2W@VIRGINIA.EDU

KEITA IKEDA, PHD

CONTACT

9195931174; KEITA@VIRGINIA.EDU

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Anesthesiology

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: October 13, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)