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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02549378
Other study ID # 1308031
Secondary ID
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


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
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