Gastrointestinal Microcirculation During Cardiopulmonary Bypass

August 5, 2014 updated by: Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Goethe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cardiac surgery patients with ecc

Description

Inclusion Criteria:

  • Patients on extracorporeal circulation

Exclusion Criteria:

  • Haemorrhoidal lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extracorporeal circulation
all patients were measured by microcirculation device O2C
Procedure: Heart Lung machine
measurement of microcirculation with O2C device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Flow in Microcirculation
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • O2C-001AHK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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