Assessment of the Repeatability of Sublingual Microcirculation Function Measurements in Healthy Volunteers and Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- FCD (Functional Capillary Density)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Healthy Volunteers
- •Inclusion Criteria:
- •ASA Physical Status I-II
- •Age 18-40 years
排除标准
- •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)
研究组 & 干预措施
Healthy Volunteers
Healthy Volunteers
Critically ill
Patients Hospitalized in the ICU
结局指标
主要结局
FCD (Functional Capillary Density)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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.)