Tissue oxygenation and perfusion and the determination of glucose subcutaneously

Tissue oxygenation and perfusion and the determination of glucose subcutaneously - TOP DOGS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34018

Enrollment

Registered

2009-04-20

Start date

2009-07-14

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

glucose metabolism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Willing and able to give written informed consent admittance to the OLVG for elective open cardiac surgery (coronary artery bypass graft [CABG]; mitral-, tricuspidal- and aortic valve surgery) age 18-85 years

Exclusion criteria

Exclusion criteria: abdominal abnormalities that inhibit sensor insertion

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Microcirculatory function expressed as % of perfused vessels as measured by OPS. 2. Microcirculatory function expressed as microvascular flow index (MFI) as measured by OPS. 3. Tissue oxygen saturation (StO2) expressed as ratio oxygenated haemoglobin to total haemoglobin as measured by near infrared spectroscopy (NIRS). 4. Systemic oxygen saturation (SpO2) expressed as % as measured by pulse oximetry. 5. APACHE II score. 6. SOFA score. 7. Glucose values expressed as mmol/l as measured by the Accu-Chek Compact plus.	—

Measure

Time frame

1. Microcirculatory function expressed as % of perfused vessels as measured by OPS. 2. Microcirculatory function expressed as microvascular flow index (MFI) as measured by OPS. 3. Tissue oxygen saturation (StO2) expressed as ratio oxygenated haemoglobin to total haemoglobin as measured by near infrared spectroscopy (NIRS). 4. Systemic oxygen saturation (SpO2) expressed as % as measured by pulse oximetry. 5. APACHE II score. 6. SOFA score. 7. Glucose values expressed as mmol/l as measured by the Accu-Chek Compact plus.

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Countries

Netherlands

Outcome results