Clinical Deterioration Clinical Trial
Official title:
Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home
NCT number | NCT06077851 |
Other study ID # | 2308603 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 3, 2023 |
Est. completion date | October 1, 2024 |
The study aims to investigate the use of wireless, continuous monitoring in patients at home including the frequency of alarms triggered by abnormal vital parameters and their significance for (re)hospitalisation/Serious Adverse Events(SAE) and/or death within 30 days.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Adult patients (=18 years) admitted (with at least one night stay) with an acute medical disease and scheduled for discharge to their own homes Adult patients (=18 years) who have contacted the EMS and, after assessment by paramedic personnel, not deemed sick enough for immediate hospital admission. Exclusion Criteria: Patients placed on palliative treatment. Acceptable chronically abnormal vital parameters of SpO2<88%, MAP<70, RR>24, or HR>110. 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 Hospital | Copenhagen | NV |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital | Emergency Medical Services, Capital Region, Denmark, Rigshospitalet, Denmark, Technical University of Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency of automatically generated alerts on deviating vital signs | per device per patient per day | 72 hours | |
Other | Number of automatically generated alerts | From all devices worn, per patient per day | 72 hours | |
Other | Frequency of alerts which are responded to by healthcare personnel | Number of alerts triggered by deviating vital signs, per patient per day | 72 hours | |
Other | Fraction of time within the study period with at least one type of data transmitted in real time from patients' homes. | 72 hours | ||
Primary | (Re)admission | Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact | within 30 days | |
Primary | Serious Adverse Events | Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE). | within 30 days | |
Primary | Mortality | within 30 days | ||
Secondary | (Re)admission | Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact | within 7 days after discharge/assessment by paramedic personnel | |
Secondary | Inquiries to the Emergency Medical Service | Defined as patients calls to 1813/112 | within 30 days | |
Secondary | Mortality and types of SAEs | Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE). | within 30 days |
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