Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration.

Not Applicable

Completed

• Conditions: Complication,Postoperative
• Interventions: Device: Active Alarms

• Registration Number: NCT04640415
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-23
• Study Start: 2021-01-11
• Primary Completion: 2022-10-30
• Study Completion: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative duration	During monitoring, for a maximum of up to 5 postoperative days or until discharge.	Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.

Secondary Outcome Measures

Name	Time	Method
Frequency of sustained deviation alerts	During monitoring, for a maximum of up to 5 postoperative days or until discharge.	Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol.
Any adverse event	7 days and 30 days after start of monitoring	Any adverse event. Criteria for each defined in protocol. Results will be compared between the case and control arm, on when it a diagnosis is made.; Based on information in patient electronic medical file.
Any serious adverse event	7 days and 30 days after start of monitoring	Any serious adverse event. Criteria for each defined in protocol. Serious Adverse Events will be determined using the criteria as defined in ICH-GCP terms.; Results will be compared between the case and control arm, on when it a diagnosis is made.; Based on information in patient electronic medical file.

Trial Locations

Locations (2)

Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark