Study of the Impact of Changes in Carbonemia on Microcirculation in Patients Achieving a Test Hypercapnia

September 14, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Study of the Impact of Changes in Carbonemia on Microcirculation in Patients - A Monocentric Study

The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.

Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .

The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.

Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

  • France
      • Saint-Etienne, France, 42055
        • Chu Saint-Etienne

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patients from achieving hypercapnia test the CHU of Saint-Etienne
  • non smoking
  • non diabetic
  • affiliated with or entitled to a social security system
  • Written consent

Exclusion Criteria:

  • subjects not performing the test hypercapnia in full
  • patients with dermatological pathology at the study area
  • patient with Raynaud's syndrome
  • Patients with known bleeding disorders
  • refusal to consent

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with a hypercapnia test
confocal microscopy patients with a hypercapnia test
Device: confocal microscopy
microvessel diameter measured by confocal microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microcirculatory flow (cells / min) measured by confocal microscopy
Time Frame: Day1
microcirculatory flow (cells / min) measured by confocal microscopy in hypocapnic patients
Day1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microvessel diameter (micrometer) measured by confocal microscopy
Time Frame: Day1
microvessel diameter (micrometer) measured by confocal microscopy in hypocapnic patients
Day1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Laurent Gergelé, MD, Chu Saint-Etienne

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

May 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 11, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1308031

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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