Microcirculation in Prehospital Medicine

NCT04265066 | Completed

• 1 other identifier: 16-031
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnostic and risk stratification are limited in emergencies. The measurement of microcirculation might identify patients with poor perfusion but compensated macrocirculation such as in beginning shock. This proof-of-concept study will examine whether sublingual prehospital sidestream dark field microscopy is feasible. This prospective observational study will include patients receiving medical aid by an emergency ambulance who had a spontaneous circulation and offer access to the sublingual mucosa. Sublingual measurement of microcirculation will be performed using a sidestream dark field camera. Video-quality will be evaluated with MIQS (microcirculation image quality score). AVA 4.3C software will calculate microcirculatory parameters.

Conditions

Emergencies

Keywords

Microcirculation; prehospital care; risk stratification

Outcome Measures

Primary Outcomes (2)

• Microcirculatory quality score (MIQS)

  MIQS by Massey et al. is an established method to validate recorded SDF-videos for their suitability for further analysis. MIQS assigns a score of optimal (0 points), suboptimal but acceptable (1 point), or unacceptable (10 points) to the categories illumination, duration, focus, content, stability, and pressure. The scoring will be done for every recorded video during the offline analysis.

  at Baseline

• Percentage of Perfusion Vessels [%]

  Measurement of sublingual microcirculation by using MicroScan® microscope. AVA 4.3C calculates automatically important microcirculatory values (Percentage of Perfusion Vessels; DeBackerDensity; Perfused DeBackerDensity; Perfused Vessel Density) according to the Second Consensus Conference

  at Baseline

Secondary Outcomes (7)

• NACA-scores

  at Baseline

• measurement of Blood pressure

  at Baseline

• measurement of Pulse rate [/per Minute]

  at Baseline

• measurement of Peripheral oxygen saturation [%]

  at Baseline

• measurement of Respiratory rate [/Minute]

  at Baseline

Study Arms (1)

Measurement of sublingual microcirculation

Diagnostic Test: microcirculation

Interventions

microcirculation DIAGNOSTIC_TEST

measurement of microcirculation

Measurement of sublingual microcirculation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who call for an acute emergency outside the hospital

You may qualify if:

• the call for an acute emergency outside the hospital with the indication for sending out an emergency doctor
• a spontaneous circulation without previous resuscitation
• informed consent
• the sublingual mucosa must be accessible

You may not qualify if:

• \<18 years
• Lacking informed consent
• time-critical disease
• previous resuscitation
• inaccessibility of sublingual area

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Emergencies

Interventions

Microcirculation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator Prof. Dr. Dr. Christian Jung

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 11, 2020
• Study Start: October 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

DE (1)