Vital Signs Monitoring in Rehabilitation Center Patients

Comorbidities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345626
• Other study ID #: Rigshospitalet, Copenhagen
• Status: Completed
• Start date: October 14, 2019
• Est. completion date: October 8, 2021

Study information

• Verified date: May 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Comorbidities

Locations

Country	Name	City	State
Denmark	Center for Rehabilitering og Akutpleje - Bystævneparken	Brønshøj

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication	Complication frequency within 30 days from study inclusion	30 days
Other	Readmission	Readmission frequency within 30 days from study inclusion	30 days
Primary	Monitoring time	Monitoring time with data from any device	96 hours
Secondary	SpO2 < 92%	Duration of SpO2 < 92%	96 hours
Secondary	SpO2 < 88%	Duration of SpO2 < 88%	96 hours
Secondary	SpO2 < 85%	Duration of SpO2 < 85%	96 hours
Secondary	SpO2 < 80%	Duration of SpO2 < 80%	96 hours
Secondary	Respiratory rate <5 breaths per minute	Duration of respiratory rate <5 breaths per minute	96 hours
Secondary	Respiratory rate <11 breaths per minute	Duration of respiratory rate <11 breaths per minute	96 hours
Secondary	Respiratory rate >24 breaths per minute	Duration of respiratory rate >24 breaths per minute	96 hours
Secondary	Respiratory rate >30 breaths per minute	Duration of respiratory rate >30 breaths per minute	96 hours
Secondary	Heart rate <30 beats per minute	Duration of heart rate <30 beats per minute	96 hours
Secondary	Heart rate <40 beats per minute	Duration of heart rate <40 beats per minute	96 hours
Secondary	Heart rate > 110 beats per minute	Duration of heart rate > 110 beats per minute	96 hours
Secondary	Heart rate > 130 beats per minute	Duration of heart rate > 130 beats per minute	96 hours
Secondary	Systolic blood pressure <70 mmHg	Number of systolic blood pressure <70 mmHg measurements	96 hours
Secondary	Systolic blood pressure <90 mmHg	Number of systolic blood pressure <90 mmHg measurements	96 hours
Secondary	Systolic blood pressure >180 mmHg	Number of systolic blood pressure >180 mmHg measurements	96 hours
Secondary	Systolic blood pressure >220 mmHg	Number of systolic blood pressure >220 mmHg measurements	96 hours