EmergenciesMicroCircPreHoNCT04265066
Microcirculation in Prehospital Medicine
An observational study of Emergencies, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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
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 group | Role | What they receive |
|---|---|---|
| Measurement of sublingual microcirculation | Not described Receives: Diagnostic Test: microcirculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
measurement of Blood pressure
Non-invasive blood-measurement will be done immediately for every emergency patient.
Measured: at Baseline
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
measurement of Peripheral oxygen saturation [%]
Non-invasive oxygen saturation measurement will be done immediately for every emergency patient using a pulsoxymeter.
Measured: at Baseline
measurement of Respiratory rate [/Minute]
Respiratory rate will be assessed visually for every emergency patient
Measured: at Baseline
measurement of microcirculation
Measurement of sublingual microcirculation by using MicroScan® microscope
Measured: at Baseline
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.
- First posted11 Feb 2020
- Study start1 Oct 2018
- Primary completion1 Sep 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Analysis of the Sublingual Microvascular Terminal Circuit in Emergency Patients - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04265066
- Acronym / sponsor ID
- MicroCircPreHo / 16-031
- Conditions
- Emergencies
- Keywords
- Microcirculation, prehospital care, risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Feb 2020 (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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of sublingual microcirculation | – | Diagnostic Test: microcirculation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who call for an acute emergency outside the hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- <18 years
- Lacking informed consent
- time-critical disease
- previous resuscitation
- inaccessibility of sublingual area
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 |
|---|---|---|
| microcirculationmeasurement of microcirculation | Diagnostic test | Measurement of sublingual microcirculation |
Primary outcome
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.
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
7 secondary outcomes
NACA-scores
Time frame: at Baseline
measurement of Blood pressure
Time frame: at Baseline
measurement of Pulse rate [/per Minute]
Time frame: at Baseline
measurement of Peripheral oxygen saturation [%]
Time frame: at Baseline
measurement of Respiratory rate [/Minute]
Time frame: at Baseline
measurement of microcirculation
Time frame: at Baseline
Intra-Hospital Mortality
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.