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

Microcirculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549378
• Other study ID #: 1308031
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: September 14, 2015
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Circulation
• Microcirculation

Intervention

Device:
• confocal microscopy
microvessel diameter measured by confocal microscopy

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microcirculatory flow (cells / min) measured by confocal microscopy	microcirculatory flow (cells / min) measured by confocal microscopy in hypocapnic patients	Day1	No
Secondary	microvessel diameter (micrometer) measured by confocal microscopy	microvessel diameter (micrometer) measured by confocal microscopy in hypocapnic patients	Day1	No