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Routine Microcirculation Measurements in Intensive Care Unit Patients and Validation by PiCCO Technology. ROUMI-study

Routine Microcirculation Measurements in Intensive Care Unit Patients and Validation by PiCCO Technology. ROUMI-study - Comparison and Validation of Cytocam-IDF imaging with PiCCO technology.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49817
Enrollment
30
Registered
2019-12-23
Start date
2020-05-30
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloedsomloop Circulation organ perfusion

Interventions

None listed

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Should be under PiCCO monitorization with routine clinic indication o Should be older than 18 years o Be suitable for monitoring in the intensive care unit o Eligible for sublingual microcirculatory evaluation (not to have maxillofacial injury, bleeding in the mouth)

Exclusion criteria

Exclusion criteria: o

Design outcomes

Primary

MeasureTime frame
2.1 Primary Objectives: o To investigate the correlation of microcirculatory parameter MFI measured with Cytocam-IDF with Cardiac Index measured using the trans-pulmonary hemodilution technique PiCCO. o To assess the association between the microcirculatory parameters and macro-hemodynamic parameters during admission and interventions such as fluid resuscitation and vasopressor/inotrope/vasodilator administration.

Secondary

MeasureTime frame
o To investigate the value and feasibility of routine monitoring of sublingual microcirculation as an early warning of clinical deterioration/improvement before the diagnosis can be made with laboratory, vital and hemodynamic parameters in critically ill patients. o To determine the usability of Cytocam-IDF in ICU practice, contribution for clinician's self-confidence, ease, time and cost. o To investigate the correlation between micro- and macro-circulatory alterations with global metabolic parameters, health status, laboratory/hemodynamic/vital parameters o To investigate the predictive value of microcirculation monitorization on the occurrence of complications like acute organ failure (renal failure, hepatic failure, encephalopathy, etc.) frequently seen in patients with fluid overload which may be visualized by measuring TVD and PVD alterations and compare to possible PICCO parameters for fluid overload. o To investigate the predictive value of microcirculatory alterations on patient survival. o To create a cut-off range for total vessel density, perfused vessel density and proportion of perfused vessels

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026