Outcomes of Digital Alerting Systems in Secondary Care

NCT04638738 | Unknown

• 1 other identifier: 17SM4043
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Deterioration, Clinical

Keywords

vital signs; continuous monitoring; wearable sensor

Outcome Measures

Primary Outcomes (1)

• Time to acknowledge alert

  Time to acknowledge alert on mobile device/central monitoring station

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Hospital length of stay

  through study completion, an average of 1 year

• Mortality

  through study completion, an average of 1 year

• Hospital readmissions

  through study completion, an average of 1 year

• intensive care step up

  through study completion, an average of 1 year

Study Arms (2)

Pre-implementation

Pre-implementation of digital alerting sensor systems

Post-implementation

Implementation of digital alerting sensor systems

Device: SensiumVitals wearable patch sensor

Interventions

SensiumVitals wearable patch sensor DEVICE

Wearable sensor which measures heart rate, respiratory rate, and temperature continuously.

Post-implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults admitted to general wards who will be staying at least 24h within hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

West Middlesex University Hospital

London, United Kingdom

RECRUITING

Related Publications (3)

• Iqbal FM, Joshi M, Fox R, Koutsoukou T, Sharma A, Wright M, Khan S, Ashrafian H, Darzi A. Outcomes of Vital Sign Monitoring of an Acute Surgical Cohort With Wearable Sensors and Digital Alerting Systems: A Pragmatically Designed Cohort Study and Propensity-Matched Analysis. Front Bioeng Biotechnol. 2022 Jun 27;10:895973. doi: 10.3389/fbioe.2022.895973. eCollection 2022.

  PMID: 35832414 DERIVED

• Joshi M, Ashrafian H, Arora S, Sharabiani M, McAndrew K, Khan SN, Cooke GS, Darzi A. A pilot study to investigate real-time digital alerting from wearable sensors in surgical patients. Pilot Feasibility Stud. 2022 Jul 6;8(1):140. doi: 10.1186/s40814-022-01084-2.

  PMID: 35794669 DERIVED

• Iqbal FM, Joshi M, Khan S, Ashrafian H, Darzi A. Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: Protocol for a Real-World Prospective Study Evaluating Clinical Outcomes. JMIR Res Protoc. 2021 May 4;10(5):e26240. doi: 10.2196/26240.

  PMID: 33944790 DERIVED

MeSH Terms

Conditions

Sepsis; Clinical Deterioration

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Progression; Disease Attributes

Study Officials

• Meera Joshi, MRCS, PhD

  Honorary research fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fahad M Iqbal, MBChB (hons)

CONTACT

02033326840; f.iqbal@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 20, 2020
• Study Start: October 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)