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EmergenciesMicroCircPreHoNCT04265066

Microcirculation in Prehospital Medicine

An observational study of Emergencies, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Emergencies
What is being tested?
microcirculation
How many people
25 participants
Where
1 siteGermany
Study dates
1 Oct 2018to 1 Dec 2019
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
  • Adult, Older adult

Study population: Patients who call for an acute emergency outside the hospital

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Division of Cardiology, Pulmonary Disease and Vascular Medicine

    Düsseldorf, 40225

Other trials in Germany

About this study

Official title: Prehospital Analysis of the Sublingual Microvascular Terminal Circuit in Emergency Patients - a Prospective Observational Study

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.

Read the detailed description

Risk stratification is a key element in emergency medicine and there is great interest to identify and validate novel tools and parameters. These tools must be are easy to handle even in the emergency setting by emergency physicians and paramedics. The main challenge for these tools is to identify critically ill patients, but usually, an ambulance disposes on clinical examination and basic hemodynamic values. Therefore, diagnostic tools are limited to the assessment of macrocirculatory values, which are not very reliable and might not necessarily reflect factual organ perfusion. Focusing only on macrocirculation might mask already ongoing impaired organ perfusion as tissue hypoxia is crucial and microcirculatory collapse or at least dysregulation occurs very early. Reduced microcirculation might result in attenuated cellular nutrient and oxygen supply that might result in severe cell damage. In fact, impaired microcirculation is ubiquitous in shock and can be found even in the setting of hemodynamic compensation. An impaired microcirculation is often the very first sign of alarm for deteriorating critically ill patients. A promising way to identify patients with impaired microcirculation is the use of sublingual IDF- and SDF-measurement (IDF: incident dark-field; SDF: sidestream dark field) devices as sublingual microcirculation is a suitable target because it reliably reflects organ perfusion. Measuring sublingual microcirculation has already been used to identify high-risk patients in many intra-hospital or experimental settings. These measurement tools are easy to use hand-held devices. The newest generation of SDF offers the great improvement of automatic software which independently calculates various microcirculatory parameters. Therefore, there is no need for the treating physician to interpret the videos by himself. This investigation will take place in the ambulance emergency service of the metropolitan area around Düsseldorf, Germany. To participate in the study, patients must meet the following criteria: 1) the call for an acute emergency outside the hospital with the indication for sending out an emergency doctor, 2) a spontaneous circulation without previous resuscitation, 3) informed consent, 4) the sublingual mucosa must be accessible. The following data will be collected: age, sex, cause for emergency alarm (cardiac reason, respiratory reason, gastroenterological, oncological, general internal medicine, renal, neurological, psychiatric, paediatric, traumatic), and the National Advisory Committee on Aeronautics' (NACA), that ranges from 0 = no injury, 7 = lethal injury severity score. Vital parameters (heart rate, non-invasive blood pressure, peripheral oxygen saturation) will be measured using a standard out-of-hospital monitoring device (Corpuls3 (GS Elektromedizinische Geräte G. Stemple GmbH, Kaufering, Germany)). Mean arterial pressure (MAP) will be calculated as follows: (2 * diastolic pressure + systolic pressure) /3. The capillary refill was evaluated in a standardized manner as described by Hernandez et al. Only sufficiently trained investigators will perform measurements. The microcirculation will be assessed by the implementation of the sidestream darkfield microscope (MicroScan® device, Microvision Medical, Amsterdam, The Netherlands). At the tip of the device, a highly sensitive camera digitally records the sublingual capillary network. The software analysis can directly be performed and visualized on a tablet screen. Additionally, the videos will be saved for later analysis. A suitable tablet computer will be used (Microsoft Surface Pro 4, (Redmond, Washington, USA). After acquisition of the videos, a validated automatic algorithm-software (AVA, Version 4.3 C) will perform the analyses. According to the second consensus on the assessment of sublingual microcirculation in critically ill patients (European Society of Intensive Care Medicine), the following parameters of microcirculation will be assessed both for all and for small vessels: PPV (Percentage of Perfused Vessels), NC (Number of Crossings), PNC (Perfused Number of crossings), TVD (Total Vessel Density), PVD (Perfused Vessel Density). The study plans to include at least 25 patients.

Conditions
Emergencies
Being tested
microcirculation
Keywords
Microcirculation, prehospital care, risk stratification
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • microcirculationDiagnostic test

    measurement of microcirculation

Study groups in NCT04265066
Study groupRoleWhat they receive
Measurement of sublingual microcirculationNot described
Receives: Diagnostic Test: microcirculation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at Baseline

  2. 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

    Measured: at Baseline

Secondary outcomes (7)
  1. NACA-scores

    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.

    Measured: at Baseline

  2. measurement of Blood pressure

    Non-invasive blood-measurement will be done immediately for every emergency patient.

    Measured: at Baseline

  3. measurement of Pulse rate [/per Minute]

    Non-invasive pulse rate-measurement will be done immediately for every emergency patient using a pulsoxymeter.

    Measured: at Baseline

  4. measurement of Peripheral oxygen saturation [%]

    Non-invasive oxygen saturation measurement will be done immediately for every emergency patient using a pulsoxymeter.

    Measured: at Baseline

  5. measurement of Respiratory rate [/Minute]

    Respiratory rate will be assessed visually for every emergency patient

    Measured: at Baseline

  6. measurement of microcirculation

    Measurement of sublingual microcirculation by using MicroScan® microscope

    Measured: at Baseline

  7. Intra-Hospital Mortality

    Intra-Hospital mortality will be assessed using the medical records of the hospital or direct contact to the patient.

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start1 Oct 2018
  3. Primary completion1 Sep 2019
  4. Study completion1 Dec 2019

Resources

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
Case only
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04265066
Sponsor's protocol ID
16-031
Acronym
MicroCircPreHo
Status last verified
Feb 2020
First submitted
29 Jan 2020
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Emergencies, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Feb 2020. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microcirculatory quality score (MIQS) (time frame: at Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Feb 2020.

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