Gastrointestinal Microcirculation During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01425931
First received: August 23, 2011
Last updated: August 5, 2014
Last verified: August 2014
  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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Blood Flow in Microcirculation [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01425931

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

No publications provided

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
Study First Received: August 23, 2011
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on September 22, 2014