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Gastrointestinal Microcirculation During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425931
First Posted: August 30, 2011
Last Update Posted: August 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
  Purpose

O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. The examinations are without any strain for your patient.

Determines by use of a glass fibre probe:

Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen supply of organs and tissue.

With it is possible to measure locally the amount of oxygen which is transported into the region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and subsequently to organ failure, now can be detected in an early state by use of the new sensor system.

One of these new developed sensors are used to place in rectal position during extracorporeal circulation to determine the microcirculation.


Condition Intervention
MeSH Heading Cardiac Surgical Procedures Tree Number E04.100.376 Tree Number E04.928.220 Procedure: Heart Lung machine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Blood Flow in Microcirculation [ Time Frame: 3 hours ]

Estimated Enrollment: 50
Study Start Date: June 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Extracorporeal circulation
all patients were measured by microcirculation device O2C
Procedure: Heart Lung machine
measurement of microcirculation with O2C device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiac surgery patients with ecc
Criteria

Inclusion Criteria:

  • Patients on extracorporeal circulation

Exclusion Criteria:

  • Haemorrhoidal lesions
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425931


Locations
Germany
Goethe University
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
  More Information

Responsible Party: Arndt-H. Kiessling, Head cardiovascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01425931     History of Changes
Other Study ID Numbers: O2C-001AHK
First Submitted: August 23, 2011
First Posted: August 30, 2011
Last Update Posted: August 6, 2014
Last Verified: August 2014