Agreement Between Standard and Continuous Wireless Vital Sign Measurements

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Rigshospitalet

Status

Completed

Conditions

Postoperative Patients

Study type

Observational

Funder types

Other

Identifiers

NCT05325814
WARD_SX_validation

Details and patient eligibility

About

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

Full 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

Enrollment

20 patients

Sex

All

Ages

60 to 110 years old

Volunteers

No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Device: Continuous monitoring system
Description:
Continuous monitoring system Recruited patients will be continuously monitored with Isansys Lifetouch patch, Nonin WristOx 3150, Isansys wireless blood pressure monitor (Meditech Blue BP-05) and standard monitoring at the post anesthesia care unit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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