Alterations of Conjunctival Microcirculation in Brain Dead Patients

Sponsor
Lithuanian University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02483273
Collaborator
(none)
22
1
58
0.4

Study Details

Study Description

Brief Summary

Study hypothesize that ocular microcirculation is reflecting cerebral perfusion. The purpose of this study is to evaluate ocular microcirculation in brain dead patients using side dark field (SDF) videomicroscope and compare it with microcirculatory parameters of healthy volunteers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Microcirculation videomicroscopy techniques are used to evaluate a global organ perfusion in various critical conditions using limited suitable sites available for visualisation. However, ocular microcirculation may become a window to specifically cerebral perfusion due to related blood supply, close anatomical proximity and easy accessibility for videomicroscopy. Cerebral perfusion mainly depends on cerebral flow and intracranial pressure and therefore we aim, for the first time, to demonstrate microcirculatory status of ocular conjunctiva in clinical conditions when cerebral flow is completely absent.

    In a single center open label observational study investigators analyzed conjunctival and sublingual microcirculation using SDF videomicroscopy in brain dead patients after reaching systemic hemodynamic targets to optimise perfusion of donor organs. All brain death diagnoses were confirmed by cerebral angiography. Microcirculatory images obtained and analyzed using standardized published recommendations by experts in this field. Microcirculation of sublingual and conjunctival areas were recorded in matching number of healthy volunteers using same techniques.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Alterations of Conjunctival Microcirculation in Brain Dead Patients
    Study Start Date :
    May 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2015
    Actual Study Completion Date :
    Mar 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Brain dead patients

    Brain dead patients certified by cerebral angiography.

    Healthy volunteers

    Any person with no known cerebral pathology.

    Outcome Measures

    Primary Outcome Measures

    1. Microvascular flow index (MFI) of ocular conjunctiva. [After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.]

      Conjunctival convective oxygen transport presented as MFI of small vessels mostly capillaries with diameter cutoff value of 20µm. Images of microcirculation were taken from at least three different points in each ocular conjunctiva and recorded for at least 20 seconds avoiding pressure artifacts. Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands). Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands). Video clips were then randomly blinded and later analyzed by 2 independent investigators.

    2. Total vessel density (TVD) of ocular concunctiva. [After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.]

      Conjunctival microvascular diffusion distance presented as TVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm. Images of microcirculation were taken from at least three different points in each ocular conjunctiva and recorded for at least 20 seconds avoiding pressure artifacts. Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands). Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands). Video clips were then randomly blinded and later analyzed by 2 independent investigators.

    3. Perfused vessel density (PVD) of ocular conjunctiva. [After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.]

      Conjunctival microvascular diffusion distance presented as PVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm. Images of microcirculation were taken from at least three different points in each ocular conjunctiva and recorded for at least 20 seconds avoiding pressure artifacts. Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands). Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands). Video clips were then randomly blinded and later analyzed by 2 independent investigators

    Secondary Outcome Measures

    1. Microvascular flow index (MFI) of sublingual mucosa. [After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.]

      Sublingual mucosa convective oxygen transport presented as MFI of small vessels mostly capillaries with diameter cutoff value of 20µm. Images of microcirculation were taken from at least three different points in sublingual mucosa and recorded for at least 20 seconds avoiding pressure artifacts. Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands). Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands). Video clips were then randomly blinded and later analyzed by 2 independent investigators.

    2. Total vessel density (TVD) of sublingual mucosa. [After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.]

      Sublingual mucosa microvascular diffusion distance presented as TVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm. Images of microcirculation were taken from at least three different points in sublingual mucosa and recorded for at least 20 seconds avoiding pressure artifacts. Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands). Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands). Video clips were then randomly blinded and later analyzed by 2 independent investigators.

    3. Perfused vessel density (PVD) of sublingual mucosa. [After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.]

      Sublingual mucosa microvascular diffusion distance presented as PVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm. Images of microcirculation were taken from at least three different points in sublingual mucosa and recorded for at least 20 seconds avoiding pressure artifacts. Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands). Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands). Video clips were then randomly blinded and later analyzed by 2 independent investigators.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed brain dead
    Exclusion Criteria:
    • Conjunctival or sublingual mucosa damage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lithuanian University of Health Sciences Kaunas Lithuania

    Sponsors and Collaborators

    • Lithuanian University of Health Sciences

    Investigators

    • Principal Investigator: Vidas Pilvinis, MD,PhD, Lithuanian UHS Intensive Care Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tomas Tamosuitis, Lithuanian University of Health Sciences Intensive Care Clinic Research Fellow, Lithuanian University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02483273
    Other Study ID Numbers:
    • P1-BE-2-19/2011
    First Posted:
    Jun 26, 2015
    Last Update Posted:
    Mar 3, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Tomas Tamosuitis, Lithuanian University of Health Sciences Intensive Care Clinic Research Fellow, Lithuanian University of Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2016