Clinical Deterioration Clinical Trial
Official title:
WARD-Home - Continuous Monitoring of Vital Parameters for Early Detection of Complications in Patients Discharged After Acute Medical Hospitalization
Verified date | June 2022 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The current pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs in this patient group.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 15, 2022 |
Est. primary completion date | June 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Adult patients (=18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg and Frederiksberg hospital | København NV | Region H |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Technical University of Denmark, University Hospital Bispebjerg and Frederiksberg |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Re-admission and cause of re-admission within 30-days | 30-days follow up | ||
Primary | Duration of data collection from the Lifetouch patch | Up to 8 days of monitoring | ||
Secondary | Duration of complete peripheral saturation data | Up to 8 days of monitoring | ||
Secondary | Duration of complete blood pressure data | Up to 8 days of monitoring | ||
Secondary | Cummulated duration of desaturation | Peripheral saturation below 88% and 85% | Up to 8 days of monitoring | |
Secondary | Number of events with SpO2 < 88% in at least 10 consecutive minutes | Up to 8 days of monitoring | ||
Secondary | Number of events with SpO2 < 85% in at least 5 consecutive minutes | Up to 8 days of monitoring | ||
Secondary | Number of deviating vital parameters in accordance to defined microevents | Up to 8 days of monitoring |
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