Clinical trial NCT05325814: Agreement Between Standard and Continuous Wireless Vital Sign Measurements
Official title: Agreement Between Standard and Continuous Wireless Vital Sign Measurements Following Major Abdominal Surgery: A Clinical Comparison Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Patients
Keywords: wearable devices
continuous
comparison study
validation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for major abdominal surgery at Bispebjerg and Frederiksberg, and Rigshospitalet.

Brief summary: Patients undergoing major surgery are at risk of postoperative complications. Continuous wireless monitoring outside the post-anesthesia or intensive care units may enable early detection of patient deterioration, but good accuracy of measurements is required.

This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Detailed description: Patients undergoing major surgery are at risk of postoperative complications. Complications may be preceded by abnormal vital signs. Standard monitoring at general wards is intermittent and manual, leaving the patients unobserved for extended periods.

The chance to enhance monitoring has arisen with recent technological advances in the form of small wearable and wireless devices that continuously record vital signs. Wearable devices enable continuous monitoring outside the intensive care unit and post-anesthesia care unit, thus enabling early detection of patient deterioration. However, before implementing such devices in hospital settings, good accuracy, and precision of measurements is required.

This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Eligibility criteria: Inclusion Criteria:

* ≥60 years, scheduled for major abdominal cancer surgery with planned PACU admission.

Estimated surgical intervention duration ≥2 hours.

Exclusion Criteria:

* Implanted cardioverter defibrillator or pacemaker, allergy to study devices, severe cognitive impairment assessed by Mini-Mental State Examination ≤24, or inability to cooperate in wearing the wireless monitoring equipment.

Primary outcomes:
measure: Heart rate comparisons
timeFrame: 1.5 hours (measurement interval every 15 min)
measure: Respiratory rate comparisons
timeFrame: 1.5 hours
measure: SpO2 measurements comparisons wireless vs. standard
timeFrame: 1.5 hours (measurement interval every 15 min)
measure: SpO2 measurements comparisons wireless vs. invasive
timeFrame: 1.5 hours
measure: Pulse rate comparisons
timeFrame: 1.5 hours
measure: Blood pressure comparisons wireless vs. standard
timeFrame: 1.5 hours, every 15 min
measure: Blood pressure comparisons, wireless vs. arterial BP
timeFrame: 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anesthesiology, Center for Cancer and Organ Diseases
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, Dr. Med
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Camilla Haahr-Raunkjaer, MD
role: PRINCIPAL_INVESTIGATOR
References: