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Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

NCT04473001 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2021-03-29

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • University Hospital Bispebjerg and Frederiksberg

    lead OTHER

Principal Investigators

  • Eske K Aasvang, MD, DMSc · Rigshospitalet, Centre for Cancer and Organ Diseases

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473001 on ClinicalTrials.gov