Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

NCT04473001 | Completed

• 1 other identifier: H-20002220
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Hypoglycemia

  Duration of glucose levels \< 3.9 mmol/L as measured by continuous glucose monitoring (CGM)

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

Secondary Outcomes (12)

• Active CGM

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

• Glycemic variability

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

• Mean glucose

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

• Number of hypoglycemic events

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

• Number of severe hypoglycemic events

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

Other Outcomes (3)

• Agreement between CGM and plasma glucose (PG)

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

• Duration of hypoglycemia as measured by PG

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

• Number of PG measurements

  Through the monitoring period (up to 5 days after monitoring is commenced or until discharge)

Study Arms (1)

Surgical patients

Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.

Other: Continuous vital signs and glucose monitoring

Interventions

Continuous vital signs and glucose monitoring OTHER

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)

Surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for major abdominal-, orthopedic or arterial vascular surgery.

You may qualify if:

• Adult patients (≥18 years) admitted to Rigshospitalet or Bispebjerg Hospital for major abdominal surgery (e.g. colonic resections, gastrectomy, hepatic resection etc.) or major orthopedic surgery (e.g. hip-fracture, hip and knee-arthroplasty) or major arterial vascular surgery (e.g. aortic aneurysm, iliac or femoral bypass etc.)
• Estimated duration of surgery ≥1 hour and at least one expected overnight stay postoperatively
• AND
• ● Type 1 diabetes (Clinically defined: insulin initiated at diabetes onset and treatment with multiple doses of insulin or continuous subcutaneous insulin infusion) (n=20)
• ● Type 2 diabetes treated with insulin (Clinically defined: treatment with diet or oral antidiabetic drugs for at least 6 months before insulin was started) (n =20)
• ● Type 2 diabetes treated with oral antihyperglycemic drugs and/or GLP-1 analogs (n=20)
• ● No diabetes mellitus (excluded by an admission HbA1c \<48 mmol/mol) (n=20)

You may not qualify if:

• Patient expected not to cooperate with study procedures.
• Patient allergic to plaster or silicone.
• Patients with impaired cognitive function (assessed by a Mini Mental State Examination \[MMSE\] score \<24)
• Patients admitted for palliative care only.
• Previous or currently scheduled for pancreatectomy (complete or partial)
• Patients with pacemaker or implantable cardioverter defibrillator (ICD) device

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, Danmark, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, Danmark, 2400, Denmark

Location

Related Publications (1)

• Carlsson CJ, Norgaard K, Oxboll AB, Sogaard MIV, Achiam MP, Jorgensen LN, Eiberg JP, Palm H, Sorensen HBD, Meyhof CS, Aasvang EK. Continuous Glucose Monitoring Reveals Perioperative Hypoglycemia in Most Patients With Diabetes Undergoing Major Surgery: A Prospective Cohort Study. Ann Surg. 2023 Apr 1;277(4):603-611. doi: 10.1097/SLA.0000000000005246. Epub 2021 Oct 8.

  PMID: 35129526 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eske K Aasvang, MD, DMSc

  Rigshospitalet, Centre for Cancer and Organ Diseases

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 16, 2020
• Study Start: June 26, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

DK (2)