NCT04473001

Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

Continuous Glucose Measurements to Detect Hypoglycemia in Patients Undergoing Major Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypoglycemia
• Perioperative Complication

Interventions

Type	Name	Description
OTHER	Continuous vital signs and glucose monitoring	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)

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2020-07-16
• Last updated: 2021-03-29

Locations

2 sites across 1 country: Denmark