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Not yet recruiting NCT07397208

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

— Observational Critical Illness Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Critical Illness, Healthy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Primary outcome measures

  • FCD (Functional Capillary Density) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
  • MFI (Microvascular Flow Index) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
  • HI (Heterogeneity Index) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
Secondary outcome measures (5)
  • TVD (Total Vessel Density) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
  • PVD (Perfused Vessel Density) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
  • PPV (Proportion of Perfused Vessels) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
  • RBCv (Red Blood Cell Velocity) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]
  • Heart rate and its variability (HRV) [Time frame: From enrollment every 5 minutes (3 measurements per operator) - approx. 20 min.]

Eligibility 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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Medical University of Gdanks — Gdansk

Identifiers

NCT: NCT07397208 · MICRO-powt

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗