Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration. (WARD-RCT-SX)

Rigshospitalet

Status: Completed

Conditions: Complication,Postoperative

Treatments: Device: Active Alarms

Study type: Interventional

Funder types: Other

Identifiers

NCT04640415

H-20034555

Details and patient eligibility

About

The primary aim of the current study is to assess the effect of continuous wireless vital sign monitoring with generation of real-time alerts, compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards after major surgery.

We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.

Enrollment: 400 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery.
• Estimated duration of surgery ≥2 hours and at least two expected overnight stays.
• Randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively

Exclusion criteria

• Patient expected not to cooperate with study procedures.
• Allergy to plaster or silicone.
• Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination] score < 24)
• Patients admitted for palliative care only (i.e. no active treatment).
• Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
• Patients previously enrolled in the medical WARD RCT.
• Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
• Inability to give informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

No alarms

No Intervention group

Description:

Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff.

Active alarms

Active Comparator group

Description:

Patients will be connected to monitoring equipment, registering data, and data will be available to clinical staff, including alarms for vital sign deterioration.

Treatment:

Device: Active Alarms