Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission

Completed

• Conditions: Disease Attributes; Vital Sign Monitoring; Disease Progression; Clinical Deterioration
• Interventions: Device: Wireless and continuously monitoring

• Registration Number: NCT05536206
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization

Detailed Description

The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities.

This 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 i in the patients' own homes during the first days after discharge. Data will be transmitted continuously in real time from patient's homes to mobile applications for portable handheld devices such as healthcare personnel's smartphones.

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-12-01
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observed patients	Wireless and continuously monitoring	Adult patients (≥18 years) admitted with an acute medical disease and who are scheduled for discharge to their own homes within five days from inclusion.

Primary Outcome Measures

Name	Time	Method
Duration of data collection from the Lifetouch patch	Up to 72 hours of monitoring

Secondary Outcome Measures

Name	Time	Method
Number of events with SpO2 < 88% in at least 10 consecutive minutes	Up to 72 hours of monitoring
Number of deviating vital parameters in accordance to defined microevents	Up to 72 hours of monitoring
Number of events with SpO2 < 85% in at least 5 consecutive minutes	Up to 72 hours of monitoring
Duration of complete peripheral saturation data	Up to 72 hours of monitoring
Duration of complete blood pressure data	Up to 72 hours of monitoring
Cummulated duration of desaturation	Up to 72 hours of monitoring	Peripheral saturation below 88% and 85%

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, NV, Denmark