Outcomes of Digital Alerting Systems in Secondary Care

• Conditions: Sepsis; Deterioration, Clinical
• Interventions: Device: SensiumVitals wearable patch sensor

• Registration Number: NCT04638738
• Lead Sponsor: Imperial College London

Brief Summary

Why? The investigators are trying to find out if participants that suddenly deteriorate on the ward can be identified sooner by wearing a wearable sensor. This is an important study to see if the sensor works correctly in recording continuous vital observations of heart rate, respiratory rate and temperature. This information can help doctors and nurses identify un-well participants.

What? The investigators will ask the participants to wear a light wearable sensor on the chest that can be worn for 5 days. If the participants are still in hospital after this time the sensor can be changed. All sensors are disposable. The participants would not have to actively do anything to the sensor. We will also participants to complete a short questionnaire about the sensor.

Who? All participants on the ward that are admitted with a new medical or surgical problem can take part in the study. Participants undergoing a surgical procedure that require at least one overnight stay are eligible to take part in this study.

Where? This study is being conducted at West Middlesex University Hospital and St Marys Hospital Paddington. Only certain wards are being included at both sites, if the participant moves wards the sensor will be removed.

How? The study will last around 5 years and we aim to recruit 1000 participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-20
• Last Update Posted: 2020-11-20
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Admitted adults on a general medical or surgical ward, identified as suitable by the clinical team.
• Able to provide written consent

Exclusion Criteria

• pacemaker/ICD
• open chest wound injury
• skin condition preventing sensor to be worn
• participant whom withdraws consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-implementation	SensiumVitals wearable patch sensor	Implementation of digital alerting sensor systems

Primary Outcome Measures

Name	Time	Method
Time to acknowledge alert	through study completion, an average of 1 year	Time to acknowledge alert on mobile device/central monitoring station

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	through study completion, an average of 1 year	hospital length of stay
Mortality	through study completion, an average of 1 year	Mortality within 30 days following discharge
intensive care step up	through study completion, an average of 1 year	ITU step up
Hospital readmissions	through study completion, an average of 1 year

Trial Locations

Locations (1)

West Middlesex University Hospital; 🇬🇧 London, United Kingdom