ShockMICROEYENCT03406598
Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients
An observational study of Shock and Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Sepsis, Hemorrhagic Shock
- What is being tested?
- Patients in shock
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2018to 10 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)).
Who may be able to join
- 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.
Who cannot join
- Maxillofacial trauma
- Oral mucosal injuries preventing to perform the sublingual microcirculation monitoring.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Département d'Anesthésie Réanimation
Le Kremlin-Bicêtre, Île-de-France Region, 94270
Jacques DURANTEAU, PhD, 33 1 45 21 34 41, jacques.duranteau@aphp.fr
Anatole HARROIS, PhD, 33 1 45 21 34 41, anatole.harrois@aphp.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Shock, Sepsis, Hemorrhagic Shock
- Being tested
- Patients in shock
- Keywords
- Shock, Microcirculation, Nurses
- Medical subject headings
- Shock, Sepsis, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in shockOther
Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients in shock | Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion. Receives: Other: Patients in shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 4 hours during 3 days
Secondary outcomes (3)
SOFA score
To test the ability of visual analysis of sublingual microcirculation to predict organ dysfunction
Measured: Every 4 hours during 3 days
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)
Measured: Every 4 hours during 3 days
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)
Measured: Every 4 hours during 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start2 Mar 2018
- Primary completion10 Oct 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques DURANTEAU, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406598
- Sponsor's protocol ID
- K170903J
- Acronym
- MICROEYE
- Status last verified
- Sep 2021
- First submitted
- 20 Dec 2017
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23318492Tachon 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.
PubMed 24561562Tanaka 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.
PubMed 26542952Massey 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.
PubMed 23972316
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bedside Visual Analysis of Sublingual Microcirculation in ICU Patients in Shock
- ClinicalTrials.gov ID
- NCT03406598
- Acronym / sponsor ID
- MICROEYE / K170903J
- Conditions
- Shock, Sepsis, Hemorrhagic Shock
- Keywords
- Shock, Microcirculation, Nurses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 10 Oct 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in shock | – | Other: Patients in shockAnalysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Maxillofacial trauma
- Oral mucosal injuries preventing to perform the sublingual microcirculation monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients in shockAnalysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion. | Other | Patients in shock |
Primary outcome
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
3 secondary outcomes
SOFA score
Time frame: Every 4 hours during 3 days
Hemodynamic macrovascular parameters
Time frame: Every 4 hours during 3 days
Hemodynamic microvascular parameters.
Time frame: Every 4 hours during 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 23318492De 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.
- Background: PubMed 24561562Tachon 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.
- Background: PubMed 26542952Tanaka 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.
- Background: PubMed 23972316Massey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques DURANTEAU, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques DURANTEAU, PhD (+ 33 1 45 21 34 41, jacques.duranteau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured of Microvascular Flow Index (MFI) (time frame: Every 4 hours during 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406598, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.