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NCT Number: NCT07397208

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Group 1: Healthy Volunteers

Inclusion criteria

  • ASA Physical Status I-II
  • Age 18-40 years

Exclusion criteria

  • Chronic diseases
  • Chronic medication use
  • Pregnancy
  • Use of stimulants (caffeine, nicotine, alcohol) within 12 hours prior to the study
  • Lack of consent to participate

Group 2: Patients Hospitalized in the ICU

Inclusion criteria

  • Age > 18 years
  • Hospitalization in the Intensive Care Unit (ICU)
  • Requirement for vasoactive drugs (minimum norepinephrine equivalent dose >0.1μg/kg / min )
  • Mechanical ventilation via an endotracheal tube

Exclusion criteria

  • Head and craniofacial trauma
  • Pregnancy
  • Intensive fluid therapy (>200ml/h)
  • Changes in vasoactive drug dosages within 30 minutes prior to study inclusion
  • Hypothermia (body temperature <35.5 oC)
  • Fever (body temperature >38.5oC)

Treatment and study plan

Primary outcomes

  1. FCD (Functional Capillary Density)

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

    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

  2. MFI (Microvascular Flow Index)

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

    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

  3. HI (Heterogeneity Index)

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

    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

Secondary outcomes

  1. TVD (Total Vessel Density)

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

    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

  2. PVD (Perfused Vessel Density)

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

    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

  3. PPV (Proportion of Perfused Vessels)

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

    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: %

  4. RBCv (Red Blood Cell Velocity)

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

    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

  5. Heart rate and its variability (HRV)

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

    Heart rate and its variability (HRV) will be recorded using a Holter ECG monitor - electrodes on the chest. Frequency domain method will be used. The number of NN (beat to beat) intervals that match high frequency band (0.15 to 0.4 Hz) or low frequency band (0.04 to 0.15 Hz) will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Karol P. Steckiewicz, MD, PhD

CONTACT

[email protected]

+48 58 349 32 80

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 9, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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