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Clinical Trials/NCT06077851
NCT06077851
Completed
N/A

Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home

Bispebjerg Hospital1 site in 1 country83 target enrollmentOctober 3, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vital Sign Monitoring
Sponsor
Bispebjerg Hospital
Enrollment
83
Locations
1
Primary Endpoint
(Re)admission
Status
Completed
Last Updated
last month

Overview

Brief Summary

The study aims to investigate the use of wireless, continuous monitoring in patients at home including the frequency of alarms triggered by abnormal vital parameters and their significance for (re)hospitalisation/Serious Adverse Events(SAE) and/or death within 30 days.

Detailed Description

Acute hospital admissions challenge the capacity of the healthcare system. Readmission is common among patients with chronic medical diseases, and many patients admitted for acute conditions are often subsequently observed at the hospital for hours and often with one overnight stay for observation purposes alone. Recent medico technical research has allowed continuous and wireless monitoring of patients' vital signs in-hospital, but the practice at home remains uninvestigated. However, the technology has the potential to relieve hospital overcrowding by offering continuous and real time analytics of vital signs in high-risk patients at home.

Registry
clinicaltrials.gov
Start Date
October 3, 2023
End Date
November 30, 2025
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emilie Sigvardt

Principal investigator

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients (≥18 years) admitted (with at least one night stay) with an acute medical disease and scheduled for discharge to their own homes
  • Adult patients (≥18 years) who have contacted the EMS and, after assessment by paramedic personnel, not deemed sick enough for immediate hospital admission.

Exclusion Criteria

  • Patients placed on palliative treatment.
  • Acceptable chronically abnormal vital parameters of SpO2\<88%, MAP\<70, RR\>24, or HR\>
  • Allergy to plaster, plastic, or silicone.
  • A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
  • If the patient was deemed not able to open the front door when visited by the investigator.
  • Inability to give informed consent.

Outcomes

Primary Outcomes

(Re)admission

Time Frame: within 30 days

Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact

Serious Adverse Events

Time Frame: within 30 days

Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE).

Mortality

Time Frame: within 30 days

Secondary Outcomes

  • (Re)admission(within 7 days after discharge/assessment by paramedic personnel)
  • Inquiries to the Emergency Medical Service(within 30 days)
  • Mortality and types of SAEs(within 30 days)

Study Sites (1)

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