Neurological Monitoring During Extracorporeal Membrane Oxygenation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Dr. Gabor Erdoes, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02020759
First received: December 19, 2013
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

Neurological complications are frequent during extracorporeal membrane oxygenation (ECMO) representing a crucial factor for patient outcome. However, to date there is no consensus with regard to optimal neurological monitoring of patients undergoing ECMO.

The aim of this study is to monitor patients using transcranial Doppler (TCD) ultrasound and near-infrared spectroscopy (NIRS) during ECMO therapy.

The study hypothesis is that TCD and NIRS technology are sufficient tools to detect cerebral embolism and hypoperfusion during ECMO therapy.


Condition Intervention
Complication of Extracorporeal Membrane Oxygenation
Cerebral Embolism
Cerebral Hypoperfusion
Device: Transcranial Doppler Ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multimodal Neurological Monitoring in Patients Undergoing Extracorporeal Membrane Oxygenation (ECMO) - a Prospective Observational Pilot Study.

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Cerebral embolic load [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage


Secondary Outcome Measures:
  • Regional cerebral oxygenation [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Regional cerebral oxygenation is measured in a 30 minutes-interval during ECMO usage.


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient on ECMO
Neurological monitoring
Device: Transcranial Doppler Ultrasound
Transcranial Doppler Ultrasound is used to monitor cerebral embolism Near-Infrared Spectroscopy is used to detect cerebral hypoperfusion
Other Name: Near-Infrared Spectroscopy

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECMO Therapy due to respiratory or cardiac failure
  • Age > 18 yrs.
  • Signed informed consent

Exclusion Criteria:

  • Inclusion in an other clinical study
  • Gravidity
  • Cerebral disease of any cause (e.g. intracerebral hemorrhage, stroke)
  • Sepsis and related conditions affecting the brain (septic cerebral embolism)
  • Allergy against materials of one of the medical device used in the study (transcranial Doppler, Near- infrared spectroscopy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020759

Contacts
Contact: Gabor Erdoes, MD 0043 1 40400 ext 4102 erdoesgabor@gmail.com
Contact: Ulrich Klein, MD 0043 1 40400 ext 4102 ulrich.klein@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gabor Erdoes, MD    0043 40400 ext 4102    erdoesgabor@gmail.com   
Contact: Klaus Markstaller, Md, PhD    0043 40400 ext 4102    klaus.markstaller@meduniwien.ac.at   
Principal Investigator: Gabor Erdoes, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gabor Erdoes, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Dr. Gabor Erdoes, Dr Gabor Erdoes, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02020759     History of Changes
Other Study ID Numbers: 1557/2013
Study First Received: December 19, 2013
Last Updated: December 24, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Intracranial Embolism and Thrombosis
Embolism and Thrombosis
Intracranial Embolism
Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Thrombosis

ClinicalTrials.gov processed this record on July 26, 2014