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Clinical Trials/NCT05345626
NCT05345626
Completed
Not Applicable

It is Possible to Continuous Monitor Vital Signs in Patients Discharged a Rehabilitation Center - An Observational Feasibility Study

Rigshospitalet, Denmark1 site in 1 country20 target enrollmentOctober 14, 2019
ConditionsComorbidities

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Comorbidities
Sponsor
Rigshospitalet, Denmark
Enrollment
20
Locations
1
Primary Endpoint
Monitoring time
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Some patients unable to return home from hospital due to physical or mental illness will be discharged to a rehabilitation home to restore strength and rehabilitate. This study attempts to examine if it is possible to continuously monitor the vital signs in patients discharged to a rehabilitation center and whether wearable devices will detect more abnormal vital signs than the rehabilitation facility, as well as complication and readmission rates.

Detailed Description

Patients who are ready to leave the hospital but are deemed unable to return home are discharged to a rehabilitation center to regain strength and performance. Vital signs are only measured when deemed necessary at the rehabilitation center, in contrast to hospital wards, where vital signs are measured intermittently and manually every 8-12 hours. Wearable devices that continuously monitor a patient's vital signs may be able to detect patients who are deteriorating, as abnormal vital signs often precede a physiologic decline This study aims to determine whether it is possible to continuously monitor patients discharged to a rehabilitation center and detect more abnormal vital signs than measurements from the rehabilitation center. By attaching three wearable devices to 20 patients, we wished to record the vital signs for up to 96 hours, documenting abnormal vital signs as well as complications - and readmission rates.

Registry
clinicaltrials.gov
Start Date
October 14, 2019
End Date
October 8, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eske Kvanner Aasvang

Professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • discharged to the rehabilitation center after surgery or; diagnosed with ischemic heart disease, chronic heart disease, apoplexia cerebri, chronic obstructive pulmonary disease, or diabetes.
  • Inclusion less than 72 h from rehabilitation admission

Exclusion Criteria

  • Unable to give informed consent
  • Implanted pacemaker or cardioverter-defibrillator
  • allergic to plaster, plastic, silicone

Outcomes

Primary Outcomes

Monitoring time

Time Frame: 96 hours

Monitoring time with data from any device

Secondary Outcomes

  • Respiratory rate >24 breaths per minute(96 hours)
  • Heart rate <30 beats per minute(96 hours)
  • Systolic blood pressure <70 mmHg(96 hours)
  • Systolic blood pressure <90 mmHg(96 hours)
  • SpO2 < 92%(96 hours)
  • Heart rate > 110 beats per minute(96 hours)
  • Heart rate > 130 beats per minute(96 hours)
  • Heart rate <40 beats per minute(96 hours)
  • Systolic blood pressure >180 mmHg(96 hours)
  • SpO2 < 88%(96 hours)
  • SpO2 < 80%(96 hours)
  • Respiratory rate <5 breaths per minute(96 hours)
  • Respiratory rate <11 breaths per minute(96 hours)
  • SpO2 < 85%(96 hours)
  • Respiratory rate >30 breaths per minute(96 hours)
  • Systolic blood pressure >220 mmHg(96 hours)

Study Sites (1)

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