Neurological Monitoring During Extracorporeal Membrane Oxygenation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 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: January 4, 2015
Last verified: January 2015
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing ECMO therapy unter intensive care conditions

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: January 4, 2015
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on July 30, 2015