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Completed

NCT Number: NCT04640415

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

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.

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Key information

Conditions

Complication,Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Copenhagen NV, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Alarms

Device

Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds for more than a set duration. Continuous vital sign data will also be available to clinical staff.

Primary outcomes

  1. Cumulative duration

    Time frame: 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 outcomes

  1. Frequency of sustained deviation alerts

    Time frame: 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.

  2. Any adverse event

    Time frame: 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.

  3. Any serious adverse event

    Time frame: 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.

Other outcomes

  1. Length of hospital stay

    Time frame: 30 postoperative days and 6 months

    Length of hospital stay

  2. Patient related post-admission healthcare expenses

    Time frame: 2 years

    Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses

  3. Staff response time (intervention group only)

    Time frame: During monitoring, for a maximum of up to 5 postoperative days or until discharge, whichever comes first

    Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Bispebjerg Hospital
  • Odense University Hospital
  • Technical University of Denmark

Registry information

Official study title

Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients After Major Surgery. A Randomized Controlled Trial.

Acronym: WARD-RCT-SX

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 23, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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