NCT04640415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

November 12, 2020

Last Update Submit

June 16, 2023

Conditions

Complication,Postoperative

Keywords

Wireless MonitoringVital signsPhysiologic deterioration

Outcome Measures

Primary Outcomes (1)

  • Cumulative duration

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

    During monitoring, for a maximum of up to 5 postoperative days or until discharge.

Secondary Outcomes (3)

  • Frequency of sustained deviation alerts

    During monitoring, for a maximum of up to 5 postoperative days or until discharge.

  • Any adverse event

    7 days and 30 days after start of monitoring

  • Any serious adverse event

    7 days and 30 days after start of monitoring

Other Outcomes (3)

  • Length of hospital stay

    30 postoperative days and 6 months

  • Patient related post-admission healthcare expenses

    2 years

  • Staff response time (intervention group only)

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

Study Arms (2)

No alarms

NO INTERVENTION

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

Active alarms

ACTIVE COMPARATOR

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

Device: Active Alarms

Interventions

Active AlarmsDEVICE

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.

Active alarms

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Molgaard J, Gronbaek KK, Rasmussen SS, Eiberg JP, Jorgensen LN, Achiam MP, Rohrsted M, Singh UM, Hoang TH, Sogaard M, Meyhoff CS, Aasvang EK. Continuous Vital Sign Monitoring at the Surgical Ward for Improved Outcomes After Major Noncardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2025 Oct 1;141(4):807-817. doi: 10.1213/ANE.0000000000007606. Epub 2025 Jul 1.

    PMID: 40591492DERIVED

Related Links

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jesper Mølgaard, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Eske K Aasvang, MD, DMSc

    Rigshospitalet, Denmark

    STUDY CHAIR

  • Christian S Meyhoff, MD, PhD

    Bispebjerg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d student

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 23, 2020

Study Start

January 11, 2021

Primary Completion

October 30, 2022

Study Completion

May 30, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)