Critical Illness, Healthy
Conditions
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).
Interventions
None listed
Sponsors
Medical University of Gdansk
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FCD (Functional Capillary Density) | 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 |
| MFI (Microvascular Flow Index) | 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 |
| HI (Heterogeneity Index) | 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
| Measure | Time frame | Description |
|---|---|---|
| TVD (Total Vessel Density) | 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 |
| PVD (Perfused Vessel Density) | 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 |
| PPV (Proportion of Perfused Vessels) | 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: % |
| RBCv (Red Blood Cell Velocity) | 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 |
| Heart rate and its variability (HRV) | 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. |
Countries
Poland
Contacts
CONTACTKarol P. Steckiewicz, MD, PhD
PRINCIPAL_INVESTIGATORKarol P. Steckiewicz, MD, PhD
Medical University of Gdansk
PRINCIPAL_INVESTIGATORRadosław Owczuk, MD, PhD, DSc, Prof.
Medical University of Gdansk
Outcome results
None listed