The applicant and research team partners have over the last years developed the WARD project (Wireless Assessment of Respiratory and circulatory Distress), using wireless continuous monitoring of vital signs in high-risk patients undergoing major abdominal surgery. An important perioperative indicator not currently included in the WARD project is continuous glucose monitoring (CGM), which may not only predict and identify hypo- and hyperglycemia, but also utilize the information from variations in blood glucose in combination with other changes in vital signs to predict surgical complications in all patients. The current study involves the inclusion of 80 patients, scheduled for major abdominal, orthopedic or vascular surgery, to be monitored with CGM in addition to the currently measured vital signs. The project is a prospective, observational, clinical study, describing and analyzing variations in perioperative blood glucose levels and vital signs, and the relation to adverse clinical outcomes. Patients scheduled for elective surgery will preferentially be recruited at the preoperative assessment at a maximum of 30 days before surgery. CGM and monitoring of the remaining vital sign modalities will commence on the day of surgery. Patients admitted for acute surgery will be recruited preoperatively and CGM as well monitoring of the remaining vital sign modalities will commence as soon as possible. The patients will be monitored with CGM for up to 10 days and with the remaining modalities for up to 5 days or for all modalities until discharge or withdrawal of consent.
Study Type
OBSERVATIONAL
Enrollment
70
The patients will have the following parameters and vital signs continuously monitored using wireless equipment: * Glucose measurements (quasi-continuous, every 5 minutes) * Heart rate * Heart rhythm (single-lead ECG; quasi-continuous, 10 seconds every minute) * Signs of cardiac ischemia (single-lead ECG; quasi-continuous, 10 seconds every minute) * Respiration rate * Oxygen saturation of arterial hemoglobin (%SpO2) * Perfusion index (ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue) * Blood pressure (quasi-continuous; every 30-60 minutes) * Skin temperature * Electrodermal activity * Ambulatory activity (accelerometry)
Rigshospitalet
Copenhagen, Danmark, Denmark
Bispebjerg Hospital
Copenhagen, Danmark, Denmark
Hypoglycemia
Duration of glucose levels \< 3.9 mmol/L as measured by continuous glucose monitoring (CGM)
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Active CGM
% of study time with active CGM and data stored on the secure server
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Glycemic variability
Glycemic variability (%CV, SD)
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Mean glucose
Mean glucose (mmol/L).
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Number of hypoglycemic events
Median number of hypoglycemic events per patient per day; glucose \< 3.9 mmol/L, \>15 minutes
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Number of severe hypoglycemic events
Median number of severe hypoglycemic events per patient per day; glucose \< 3.0 mmol/L, \>15 minutes
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Number of fasting hypoglycemia events
Median number of hypoglycemia events during perioperative fasting; glucose \< 3.9 mmol/L, \>15 minutes
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Duration of fasting hypoglycemia events
Duration of hypoglycemia events during perioperative fasting, glucose \< 3.9 mmol/L
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
% of readings and time below range (TBR)
* % of readings and time in range 3.0-3.8 mmol/L * % of readings and time \<3.0 mmol/L
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
% of readings and time in range (TIR)
○ % of readings and time in range 3.9-10.0 mmol/L.
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
% of readings and time above range (TAR)
* % of readings and time in range 10.1-13.9 mmol/L. * % of readings and time \>13.9 mmol/L.
Time frame: Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)
Adverse clinical outcomes
Occurrence and severity of a range of predefined adverse clinical outcomes.
Time frame: Until 30 days after monitoring is commenced
Readmission or death
Occurrence of readmission and/or death.
Time frame: Until 6 months after monitoring is commenced
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