Outcomes of Digital Alerting Systems in Secondary Care

Sepsis Clinical Trial

Official title:

Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: a Prospective Evaluation of Clinical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638738
• Other study ID #: 17SM4043
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: September 2021

Study information

• Verified date: November 2020
• Source: Imperial College London
• Contact: Fahad M Iqbal, MBChB (hons)
• Phone: 02033326840
• Email: f.iqbal[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinical Deterioration
• Deterioration, Clinical
• Sepsis

Intervention

Device:
• SensiumVitals wearable patch sensor
Wearable sensor which measures heart rate, respiratory rate, and temperature continuously.

Locations

Country	Name	City	State
United Kingdom	West Middlesex University Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to acknowledge alert	Time to acknowledge alert on mobile device/central monitoring station	through study completion, an average of 1 year
Secondary	Hospital length of stay	hospital length of stay	through study completion, an average of 1 year
Secondary	Mortality	Mortality within 30 days following discharge	through study completion, an average of 1 year
Secondary	Hospital readmissions		through study completion, an average of 1 year
Secondary	intensive care step up	ITU step up	through study completion, an average of 1 year