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

NCT07397208 | Not Yet Recruiting

• 1 other identifier: MICRO-powt
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Critical Illness; Healthy

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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

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

• 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

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

Secondary Outcomes (5)

• TVD (Total Vessel Density)

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

• PVD (Perfused Vessel Density)

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

• PPV (Proportion of Perfused Vessels)

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

• RBCv (Red Blood Cell Velocity)

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

• Heart rate and its variability (HRV)

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

Study Arms (2)

Healthy Volunteers

Healthy Volunteers

Critically ill

Patients Hospitalized in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• 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
• Head and craniofacial trauma
• Pregnancy
• Intensive fluid therapy (\>200ml/h)
• Hypothermia (body temperature \<35.5 oC)
• Fever (body temperature \>38.5oC)

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdanks

Gdansk, Poland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karol P. Steckiewicz, MD, PhD

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

• Radosław Owczuk, MD, PhD, DSc, Prof.

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karol P. Steckiewicz, MD, PhD

CONTACT

+48 58 349 32 80; karol.steckiewicz@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 7, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)