Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients

Sepsis Clinical Trial

— MICROEYE  

Official title:

Impact of Bedside Visual Analysis of Sublingual Microcirculation in ICU Patients in Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03406598
• Other study ID #: K170903J
• Status: Recruiting
• Start date: March 2, 2018
• Est. completion date: October 10, 2021

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jacques DURANTEAU, PhD
• Phone: + 33 1 45 21 34 41
• Email: jacques.duranteau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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:

1. To test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction (SOFA score)

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 10, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Sepsis
• Shock
• Shock, Hemorrhagic

Intervention

Other:
• Patients in shock
Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.

Locations

Country	Name	City	State
France	Département d'Anesthésie Réanimation	Le Kremlin-Bicêtre	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Tanaka S, Harrois A, Nicolaï 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured of Microvascular Flow Index (MFI)	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	SOFA score	To test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction	Every 4 hours during 3 days
Secondary	Hemodynamic macrovascular parameters	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
Secondary	Hemodynamic microvascular parameters.	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