Assessment of the Repeatability of Sublingual Microcirculation Function Measurements in Healthy Volunteers and Critically Ill Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Gdansk

About this trial

The assessment of microcirculatory function plays a pivotal role in perioperative medicine and intensive care. One promising method for evaluating microcirculatory function is the microscopic analysis of the oral mucosal microvasculature. However, this method is not currently fully validated.

The aim of this study is to assess the repeatability of sublingual microcirculation measurements using the CytoCam-IDF device (Braedius Medical).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA Physical Status I-II

Age 18-40 years

Disqualifiers

Chronic diseases

Chronic medication use

Pregnancy

Use of stimulants (caffeine, nicotine, alcohol) within 12 hours prior to the study

Trial population

Patients hospitalized in the ICU at the University Clinical Center in Gdańsk, or healthy volunteers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Healthy Volunteers
Group B: Critically ill

Trial outcomes

Primary outcomes

1

FCD (Functional Capillary Density)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed by the same two individuals Unit of measurement: mm/mm\^2

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.
2

MFI (Microvascular Flow Index)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed by the same two individuals Unit of measurement: 0 - no flow / 1 -intermittent flow / 2 - sluggish flow / 3 - continuous flow

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.
3

HI (Heterogeneity Index)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed by the same two individuals Unit of measurements none, relative measurement

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.

Secondary outcomes

1

TVD (Total Vessel Density)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed by the same two individuals Unit of measurement: mm/mm\^2

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.
2

PVD (Perfused Vessel Density)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed Unit of measurement: mm/mm\^2

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.
3

PPV (Proportion of Perfused Vessels)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed by the same two individuals Unit of measurement: %

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.
4

RBCv (Red Blood Cell Velocity)

Sublingual Microcirculation Assessment Sublingual microcirculation will be assessed using the CytoCam-IDF camera (Braedius Medical, Huizen, The Netherlands). The measurement technique involves gently applying the microscope probe with a disposable cap to the sublingual mucosa and recording short video sequences. The device utilizes green LED light to visualize moving blood cells, allowing for subsequent computerized analysis of capillary density and flow quality within the microvessels. Two operators will perform 3 series of measurements at 5-minute intervals with Cytocam - IDF microcirculation camera. Each series will consist of measurements taken from 3 adjacent sites. All measurements will be performed by the same two individuals Unit of measurement: mm/s

Time frame
From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.

Other outcomes

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