Microcirculation in Prehospital Medicine (MicroCircPreHo)
Prehospital Analysis of the Sublingual Microvascular Terminal Circuit in Emergency Patients - a Prospective Observational Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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-
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Duesseldorf, Germany, 40225
- Division of Cardiology, Pulmonary Disease and Vascular Medicine
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- <18 years
- Lacking informed consent
- time-critical disease
- previous resuscitation
- inaccessibility of sublingual area
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Measurement of sublingual microcirculation
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measurement of microcirculation
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microcirculatory quality score (MIQS)
Time Frame: at Baseline
|
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.
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at Baseline
|
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Percentage of Perfusion Vessels [%]
Time Frame: at Baseline
|
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
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at Baseline
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NACA-scores
Time Frame: at Baseline
|
The National Advisory Committee on Aeronautics' (NACA) score ranges from 0 = no injury, 7 = lethal injury severity score and is an established method to estimate the severity of disease of emergency patients.
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at Baseline
|
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measurement of Blood pressure
Time Frame: at Baseline
|
Non-invasive blood-measurement will be done immediately for every emergency patient.
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at Baseline
|
|
measurement of Pulse rate [/per Minute]
Time Frame: at Baseline
|
Non-invasive pulse rate-measurement will be done immediately for every emergency patient using a pulsoxymeter.
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at Baseline
|
|
measurement of Peripheral oxygen saturation [%]
Time Frame: at Baseline
|
Non-invasive oxygen saturation measurement will be done immediately for every emergency patient using a pulsoxymeter.
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at Baseline
|
|
measurement of Respiratory rate [/Minute]
Time Frame: at Baseline
|
Respiratory rate will be assessed visually for every emergency patient
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at Baseline
|
|
measurement of microcirculation
Time Frame: at Baseline
|
Measurement of sublingual microcirculation by using MicroScan® microscope
|
at Baseline
|
|
Intra-Hospital Mortality
Time Frame: up to 1 year
|
Intra-Hospital mortality will be assessed using the medical records of the hospital or direct contact to the patient.
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up to 1 year
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 16-031
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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