NCT02549378

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

September 11, 2015

Last Update Submit

September 14, 2015

Conditions

Keywords

microcirculationconfocal microscopyhypocapnia

Outcome Measures

Primary Outcomes (1)

  • microcirculatory flow (cells / min) measured by confocal microscopy

    microcirculatory flow (cells / min) measured by confocal microscopy in hypocapnic patients

    Day1

Secondary Outcomes (1)

  • microvessel diameter (micrometer) measured by confocal microscopy

    Day1

Study Arms (1)

patients with a hypercapnia test

EXPERIMENTAL

confocal microscopy patients with a hypercapnia test

Device: confocal microscopy

Interventions

microvessel diameter measured by confocal microscopy

patients with a hypercapnia test

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Hypocapnia

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Laurent Gergelé, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

May 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations