Study to assess the accuracy of two continuous glucose monitors in relation to the microcirculatory function at the adult intensive care.
Completed
- Conditions
- continuous glucose monitoring (continue glucose monitoring)microcirculation (microcirculatie)intensive care unit (intensive care)cardiothoracic surgery (cardiothoracale chirurgie)
- Registration Number
- NL-OMON23067
- Lead Sponsor
- P.H.J. van der Voort, MD, PhDOnze Lieve Vrouwen GasthuisOosterpark 9, 1091 AC Amsterdam, the NetherlandsEmail: p.h.j.vandervoort@olvg.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Admission to the hospital for elective open cardiac surgery (coronaty artery bypass graftl mitral-, tricuspidal- and aortic valve surgery);
2. Age 18-85 years;
Exclusion Criteria
Abdominal abnormalities that inhibit sensor insertion.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in glucose values (mmol/l) measured by the two CGMs, Guardian RT and FreeStyle Navigator, compared to 'gold standard' blood glucose values measured by the Accu-Chek Compact Plus (mmol/l), expressed as mean absolute difference (MAD) of glucose values.
- Secondary Outcome Measures
Name Time Method 1. Microcirculatory function expressed as % of perfused vessels as measured by OPS;<br /><br>2. Microcirculatory function expressed as microvascular flow index (MFI) as measured by OPS;<br /><br>3. Tissue oxygen saturation (StO2) expressed as ratio oxygenated haemoglobin to total haemoglobin as measured by near infrared spectroscopy (NIRS);<br /><br>4. Systemic oxygen saturation (SpO2) expressed as % as measured by pulse oximetry;<br /><br>5. APACHE II score;<br /> <br>6. SOFA score.<br>