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Completed

NCT Number: NCT05345626

Vital Signs Monitoring in Rehabilitation Center Patients

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.

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Key information

Conditions

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Rehabilitering og Akutpleje - Bystævneparken

Brønshøj, 2700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Monitoring time

    Time frame: 96 hours

    Monitoring time with data from any device

Secondary outcomes

  1. SpO2 < 92%

    Time frame: 96 hours

    Duration of SpO2 < 92%

  2. SpO2 < 88%

    Time frame: 96 hours

    Duration of SpO2 < 88%

  3. SpO2 < 85%

    Time frame: 96 hours

    Duration of SpO2 < 85%

  4. SpO2 < 80%

    Time frame: 96 hours

    Duration of SpO2 < 80%

  5. Respiratory rate <5 breaths per minute

    Time frame: 96 hours

    Duration of respiratory rate <5 breaths per minute

  6. Respiratory rate <11 breaths per minute

    Time frame: 96 hours

    Duration of respiratory rate <11 breaths per minute

  7. Respiratory rate >24 breaths per minute

    Time frame: 96 hours

    Duration of respiratory rate >24 breaths per minute

  8. Respiratory rate >30 breaths per minute

    Time frame: 96 hours

    Duration of respiratory rate >30 breaths per minute

  9. Heart rate <30 beats per minute

    Time frame: 96 hours

    Duration of heart rate <30 beats per minute

  10. Heart rate <40 beats per minute

    Time frame: 96 hours

    Duration of heart rate <40 beats per minute

  11. Heart rate > 110 beats per minute

    Time frame: 96 hours

    Duration of heart rate > 110 beats per minute

  12. Heart rate > 130 beats per minute

    Time frame: 96 hours

    Duration of heart rate > 130 beats per minute

  13. Systolic blood pressure <70 mmHg

    Time frame: 96 hours

    Number of systolic blood pressure <70 mmHg measurements

  14. Systolic blood pressure <90 mmHg

    Time frame: 96 hours

    Number of systolic blood pressure <90 mmHg measurements

  15. Systolic blood pressure >180 mmHg

    Time frame: 96 hours

    Number of systolic blood pressure >180 mmHg measurements

  16. Systolic blood pressure >220 mmHg

    Time frame: 96 hours

    Number of systolic blood pressure >220 mmHg measurements

Other outcomes

  1. Complication

    Time frame: 30 days

    Complication frequency within 30 days from study inclusion

  2. Readmission

    Time frame: 30 days

    Readmission frequency within 30 days from study inclusion

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
May 13, 2022

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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