- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406598
Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients (MICROEYE)
Impact of Bedside Visual Analysis of Sublingual Microcirculation in ICU Patients in Shock
In shock patients, fluid resuscitation, infusion of vasopressors and transfusion are guided on hemodynamic macrovascular parameters. Analysis of sublingual microcirculation in shock patients is predictive of mortality and organ dysfunction. To optimize the quality of the resuscitation in shock patients, it could be useful to have an assessment of sublingual microcirculation in addition to the macrovascular parameters usually assessed by the nurses. But, this requires to have a monitor of sublingual microcirculation easy to use and to analyze at the bedside.
The primary outcome of the present study is to test the ability of visual analysis of sublingual microcirculation by nurses to predict needs for fluid challenge, vasopressors or transfusion in patients in shock. After ICU admission and study inclusion, the nurses in charge of the patient will perform a set of measurements of macrocirculatory and microcirculatory parameters every 4 h during the first three days after ICU admission and before and after every hemodynamic therapeutic intervention, such as fluid challenge, transfusion of red blood cells or change in catecholamine rate.
The secondary outcomes are to test 1/ to test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction (SOFA score), and 2/ to evaluate the relationship between hemodynamic macrovascular and microvascular parameters. Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)) will be included. In addition, patients will be included only when patients will obviously stay more than 24 hours in the ICU.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In shock patients, fluid resuscitation, infusion of vasopressors and transfusion are guided on hemodynamic macrovascular parameters as arterial pressure, cardiac output, lactate and diuresis. Analysis of sublingual microcirculation in shock patients is predictive of mortality and organ dysfunction. To optimize the quality of the resuscitation in shock patients, it could be useful to have an assessment of sublingual microcirculation in addition to the macrovascular parameters usually assessed by the nurses. But, this requires to have a monitor of sublingual microcirculation easy to use and to analyze at the bedside. In a previous study, using a side-stream dark-field (SDF) imaging device (Cytocam video microscope, Braedius®, Netherlands), the investigators have reported that a real-time nurse bedside qualitative evaluation of Microvascular flow index (MFI) had a good agreement with conventional delayed physician analysis, and was highly sensitive and specific for detecting impaired microvascular flow and low capillary density.
The primary outcome of the present study is to test the ability of visual analysis of sublingual microcirculation by nurses in patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
The secondary outcomes are:
- To test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction (SOFA score)
- To evaluate the relationship between hemodynamic macrovascular and microvascular parameters. The investigators will consider the macrovascular parameters usually collected by nurses each 4h: arterial pressure, heart rate, cardiac index, stroke volume index, global end-diastolic blood volume, extravascular lung water, the respiratory variations of pulse pressure (delta PP), lactate, hemoglobin, venous-to-arterial carbon dioxide differences (Pv-aCO2), diuresis and the microvascular parameters (MFI and capillary density).
Study design and measurements After ICU admission and study inclusion, the nurses in charge of the patient will perform a set of measurements of macrocirculatory and microcirculatory parameters every 4 h during the first three days after ICU admission and before and after every hemodynamic therapeutic intervention, such as fluid challenge, transfusion of red blood cells or change in catecholamine rate during this period.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jacques DURANTEAU, PhD
- Phone Number: + 33 1 45 21 34 41
- Email: jacques.duranteau@aphp.fr
Study Contact Backup
- Name: Anatole HARROIS, PhD
- Phone Number: + 33 1 45 21 34 41
- Email: anatole.harrois@aphp.fr
Study Locations
-
-
Ile De France
-
Le Kremlin-Bicêtre, Ile De France, France, 94270
- Recruiting
- Département d'anesthésie réanimation
-
Contact:
- Jacques DURANTEAU, PhD
- Phone Number: 33 1 45 21 34 41
- Email: jacques.duranteau@aphp.fr
-
Contact:
- Anatole HARROIS, PhD
- Phone Number: 33 1 45 21 34 41
- Email: anatole.harrois@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)).
- In addition, patients will be included only when patients will obviously stay more than 24 hours in the ICU.
Exclusion Criteria:
- Maxillofacial trauma
- Oral mucosal injuries preventing to perform the sublingual microcirculation monitoring.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients in shock
Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
|
Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measured of Microvascular Flow Index (MFI)
Time Frame: Every 4 hours during 3 days
|
Each set of measurements will consist of three successive video sequences of 20 seconds at three different sites.
The nurse will calculate the MFI score.
The image will be divided into 4 quadrants and the vessels <20 μm diameter will be assigned a score based on the predominant flow characteristics of the vessels in that quadrant (0 = absent flow; 1 = intermittent; 2 = sluggish; 3 = normal).
The values in each quadrant are averaged to give an MFI score for each sublingual site at each time point
|
Every 4 hours during 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SOFA score
Time Frame: Every 4 hours during 3 days
|
To test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction
|
Every 4 hours during 3 days
|
Hemodynamic macrovascular parameters
Time Frame: Every 4 hours during 3 days
|
To evaluate the relationship between hemodynamic macrovascular and microvascular parameters.
We will consider the macrovascular parameters usually collected by nurses each 4h: arterial pressure, heart rate, cardiac index, stroke volume index, global end-diastolic blood volume, extravascular lung water, the respiratory variations of pulse pressure (delta PP), lactate, hemoglobin, venous-to-arterial carbon dioxide differences (Pv-aCO2), diuresis and the microvascular parameters (MFI and capillary density)
|
Every 4 hours during 3 days
|
Hemodynamic microvascular parameters.
Time Frame: Every 4 hours during 3 days
|
To evaluate the relationship between hemodynamic macrovascular and microvascular parameters.
We will consider the macrovascular parameters usually collected by nurses each 4h: arterial pressure, heart rate, cardiac index, stroke volume index, global end-diastolic blood volume, extravascular lung water, the respiratory variations of pulse pressure (delta PP), lactate, hemoglobin, venous-to-arterial carbon dioxide differences (Pv-aCO2), diuresis and the microvascular parameters (MFI and capillary density)
|
Every 4 hours during 3 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacques DURANTEAU, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- De Backer D, Donadello K, Sakr Y, Ospina-Tascon G, Salgado D, Scolletta S, Vincent JL. Microcirculatory alterations in patients with severe sepsis: impact of time of assessment and relationship with outcome. Crit Care Med. 2013 Mar;41(3):791-9. doi: 10.1097/CCM.0b013e3182742e8b.
- Tachon G, Harrois A, Tanaka S, Kato H, Huet O, Pottecher J, Vicaut E, Duranteau J. Microcirculatory alterations in traumatic hemorrhagic shock. Crit Care Med. 2014 Jun;42(6):1433-41. doi: 10.1097/CCM.0000000000000223.
- Tanaka S, Harrois A, Nicolai C, Flores M, Hamada S, Vicaut E, Duranteau J. Qualitative real-time analysis by nurses of sublingual microcirculation in intensive care unit: the MICRONURSE study. Crit Care. 2015 Nov 6;19:388. doi: 10.1186/s13054-015-1106-3.
- Massey MJ, Larochelle E, Najarro G, Karmacharla A, Arnold R, Trzeciak S, Angus DC, Shapiro NI. The microcirculation image quality score: development and preliminary evaluation of a proposed approach to grading quality of image acquisition for bedside videomicroscopy. J Crit Care. 2013 Dec;28(6):913-7. doi: 10.1016/j.jcrc.2013.06.015. Epub 2013 Aug 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K170903J
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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