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

Primary Purpose

Complication,Postoperative

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Active Alarms
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complication,Postoperative focused on measuring Wireless Monitoring, Vital signs, Physiologic deterioration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bispebjerg Hospital
  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No alarms

Active alarms

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative duration
Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.

Secondary Outcome Measures

Frequency of sustained deviation alerts
Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol.
Any adverse event
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
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.

Full Information

First Posted
November 12, 2020
Last Updated
June 16, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital, Bispebjerg Hospital, Technical University of Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04640415
Brief Title
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Postsurgical Patient Deterioration.
Acronym
WARD-RCT-SX
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital, Odense University Hospital, Bispebjerg Hospital, Technical University of Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication,Postoperative
Keywords
Wireless Monitoring, Vital signs, Physiologic deterioration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No alarms
Arm Type
No Intervention
Arm Description
Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff.
Arm Title
Active alarms
Arm Type
Active Comparator
Arm Description
Patients will be connected to monitoring equipment, registering data, and data will be available to clinical staff, including alarms for vital sign deterioration.
Intervention Type
Device
Intervention Name(s)
Active Alarms
Intervention Description
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 Outcome Measure Information:
Title
Cumulative duration
Description
Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol.
Time Frame
During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Secondary Outcome Measure Information:
Title
Frequency of sustained deviation alerts
Description
Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol.
Time Frame
During monitoring, for a maximum of up to 5 postoperative days or until discharge.
Title
Any adverse event
Description
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.
Time Frame
7 days and 30 days after start of monitoring
Title
Any serious adverse event
Description
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.
Time Frame
7 days and 30 days after start of monitoring
Other Pre-specified Outcome Measures:
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
30 postoperative days and 6 months
Title
Patient related post-admission healthcare expenses
Description
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
Time Frame
2 years
Title
Staff response time (intervention group only)
Description
Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day
Time Frame
During monitoring, for a maximum of up to 5 postoperative days or until discharge, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Mølgaard, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eske K Aasvang, MD, DMSc
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christian S Meyhoff, MD, PhD
Organizational Affiliation
Bispebjerg
Official's Role
Study Chair
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen NV
State/Province
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.ward247.com
Description
Related Info

Learn more about this trial

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

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