Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients

NCT03406598 | Unknown

• 1 other identifier: K170903J
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock; Sepsis; Hemorrhagic Shock

Keywords

Shock; Microcirculation; Nurses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• SOFA score

  Every 4 hours during 3 days

• Hemodynamic macrovascular parameters

  Every 4 hours during 3 days

• Hemodynamic microvascular parameters.

  Every 4 hours during 3 days

Study Arms (1)

Patients in shock

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

Other: Patients in shock

Interventions

Patients in shock OTHER

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

Patients in shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care patients in shock who need sedation, mechanical ventilation and invasive hemodynamic monitoring (Pulse Contour Cardiac Output (PiCCO 2 device)).

You may qualify if:

• 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.

You may not qualify if:

• Maxillofacial trauma
• Oral mucosal injuries preventing to perform the sublingual microcirculation monitoring.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Département d'Anesthésie Réanimation

Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

RECRUITING

Related 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.

  PMID: 23318492 BACKGROUND

• 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.

  PMID: 24561562 BACKGROUND

• 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.

  PMID: 26542952 BACKGROUND

• 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.

  PMID: 23972316 BACKGROUND

MeSH Terms

Conditions

Shock; Sepsis; Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hemorrhage

Study Officials

• Jacques DURANTEAU, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques DURANTEAU, PhD

CONTACT

+ 33 1 45 21 34 41; jacques.duranteau@aphp.fr

Anatole HARROIS, PhD

CONTACT

+ 33 1 45 21 34 41; anatole.harrois@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 23, 2018
• Study Start: March 2, 2018
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)