Clinical trial NCT05345626: Vital Signs Monitoring in Rehabilitation Center Patients
Official title: It is Possible to Continuous Monitor Vital Signs in Patients Discharged a Rehabilitation Center - An Observational Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comorbidities
Keywords: Rehabilitation patients, wireless monitoring, vital signs
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients discharged to a rehabilitation center

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.

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

Primary outcomes:
measure: Monitoring time
timeFrame: 96 hours
Secondary outcomes:
measure: SpO2 < 92%
timeFrame: 96 hours
measure: SpO2 < 88%
timeFrame: 96 hours
measure: SpO2 < 85%
timeFrame: 96 hours
measure: SpO2 < 80%
timeFrame: 96 hours
measure: Respiratory rate <5 breaths per minute
timeFrame: 96 hours
measure: Respiratory rate <11 breaths per minute
timeFrame: 96 hours
measure: Respiratory rate >24 breaths per minute
timeFrame: 96 hours
measure: Respiratory rate >30 breaths per minute
timeFrame: 96 hours
measure: Heart rate <30 beats per minute
timeFrame: 96 hours
measure: Heart rate <40 beats per minute
timeFrame: 96 hours
measure: Heart rate > 110 beats per minute
timeFrame: 96 hours
measure: Heart rate > 130 beats per minute
timeFrame: 96 hours
measure: Systolic blood pressure <70 mmHg
timeFrame: 96 hours
measure: Systolic blood pressure <90 mmHg
timeFrame: 96 hours
measure: Systolic blood pressure >180 mmHg
timeFrame: 96 hours
measure: Systolic blood pressure >220 mmHg
timeFrame: 96 hours
Other outcomes:
measure: Complication
timeFrame: 30 days
measure: Readmission
timeFrame: 30 days
Locations:
city: Brønshøj
country: Denmark
facility: Center for Rehabilitering og Akutpleje - Bystævneparken
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: