Alterations of Conjunctival Microcirculation in Brain Dead Patients

NCT02483273 | Completed DMC

• 1 other identifier: P1-BE-2-19/2011
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Keywords

Conjunctival microcirculation; Sublingual microcirculation; Sidestream Dark Field (SDF) microscopy

Outcome Measures

Primary Outcomes (3)

• Microvascular flow index (MFI) of ocular conjunctiva.

  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.

  After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.

• Total vessel density (TVD) of ocular concunctiva.

  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.

  After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.

• Perfused vessel density (PVD) of ocular conjunctiva.

  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

  After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Brain dead patients

Brain dead patients certified by cerebral angiography.

Healthy volunteers

Any person with no known cerebral pathology.

Eligibility Criteria

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

Study Population

All single center tertiary level Neurosurgery Intensive Care unit patients angiographically confirmed brain dead.

You may qualify if:

• Diagnosed brain dead

You may not qualify if:

• Conjunctival or sublingual mucosa damage

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

Related Publications (8)

• De Backer D, Hollenberg S, Boerma C, Goedhart P, Buchele G, Ospina-Tascon G, Dobbe I, Ince C. How to evaluate the microcirculation: report of a round table conference. Crit Care. 2007;11(5):R101. doi: 10.1186/cc6118.

  PMID: 17845716 BACKGROUND

• Goedhart PT, Khalilzada M, Bezemer R, Merza J, Ince C. Sidestream Dark Field (SDF) imaging: a novel stroboscopic LED ring-based imaging modality for clinical assessment of the microcirculation. Opt Express. 2007 Nov 12;15(23):15101-14. doi: 10.1364/oe.15.015101.

  PMID: 19550794 BACKGROUND

• De Backer D, Ospina-Tascon G, Salgado D, Favory R, Creteur J, Vincent JL. Monitoring the microcirculation in the critically ill patient: current methods and future approaches. Intensive Care Med. 2010 Nov;36(11):1813-25. doi: 10.1007/s00134-010-2005-3. Epub 2010 Aug 6.

  PMID: 20689916 BACKGROUND

• Schaser KD, Settmacher U, Puhl G, Zhang L, Mittlmeier T, Stover JF, Vollmar B, Menger MD, Neuhaus P, Haas NP. Noninvasive analysis of conjunctival microcirculation during carotid artery surgery reveals microvascular evidence of collateral compensation and stenosis-dependent adaptation. J Vasc Surg. 2003 Apr;37(4):789-97. doi: 10.1067/mva.2003.139.

  PMID: 12663979 BACKGROUND

• Miller MM, Chang T, Keating R, Crouch E, Sable C. Blood flow velocities are reduced in the optic nerve of children with elevated intracranial pressure. J Child Neurol. 2009 Jan;24(1):30-5. doi: 10.1177/0883073808321050.

  PMID: 19168816 BACKGROUND

• Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9.

  PMID: 22573638 BACKGROUND

• Pranskunas A, Vellinga NA, Pilvinis V, Koopmans M, Boerma EC. Microcirculatory changes during open label magnesium sulphate infusion in patients with severe sepsis and septic shock. BMC Anesthesiol. 2011 Jun 14;11:12. doi: 10.1186/1471-2253-11-12.

  PMID: 21672227 BACKGROUND

• Tamosuitis T, Pranskunas A, Balciuniene N, Pilvinis V, Boerma EC. Conjunctival microcirculatory blood flow is altered but not abolished in brain dead patients: a prospective observational study. BMC Neurol. 2016 Jul 11;16:95. doi: 10.1186/s12883-016-0618-z.

  PMID: 27401581 DERIVED

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vidas Pilvinis, MD,PhD

  Lithuanian UHS Intensive Care Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lithuanian University of Health Sciences Intensive Care Clinic Research Fellow

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 26, 2015
• Study Start: May 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

LI (1)