SepsisNCT04638738
Outcomes of Digital Alerting Systems in Secondary Care
An observational study of Sepsis and Deterioration, Clinical, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Deterioration, Clinical
- What is being tested?
- SensiumVitals wearable patch sensor
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults admitted to general wards who will be staying at least 24h within hospital.
Who may be able to join
- Admitted adults on a general medical or surgical ward, identified as suitable by the clinical team.
- Able to provide written consent
Who cannot join
- pacemaker/ICD
- open chest wound injury
- skin condition preventing sensor to be worn
- participant whom withdraws consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
West Middlesex University Hospital
London
Sadia Khan, MRCP, sadia.khan@chelwest.nhs.uk
About this study
Official title: Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: a Prospective Evaluation of Clinical Outcomes
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.
Read more
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
- Being tested
- SensiumVitals wearable patch sensor
- Keywords
- vital signs, continuous monitoring, wearable sensor
- Medical subject headings
- Sepsis, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensiumVitals wearable patch sensorDevice
Wearable sensor which measures heart rate, respiratory rate, and temperature continuously.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation | Pre-implementation of digital alerting sensor systems | |
| Post-implementation | Implementation of digital alerting sensor systems Receives: Device: SensiumVitals wearable patch sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to acknowledge alert
Time to acknowledge alert on mobile device/central monitoring station
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Hospital length of stay
hospital length of stay
Measured: through study completion, an average of 1 year
Mortality
Mortality within 30 days following discharge
Measured: through study completion, an average of 1 year
Hospital readmissions
Measured: through study completion, an average of 1 year
intensive care step up
ITU step up
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Oct 2017
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meera Joshi, MRCS, PhD, Principal investigator, Honorary research fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638738
- Sponsor's protocol ID
- 17SM4043
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35832414Joshi 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.
PubMed 35794669Iqbal 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.
PubMed 33944790
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: a Prospective Evaluation of Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04638738
- Acronym / sponsor ID
- 17SM4043
- Conditions
- Sepsis, Deterioration, Clinical
- Keywords
- vital signs, continuous monitoring, wearable sensor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation | – | –Pre-implementation of digital alerting sensor systems |
| Post-implementation | – | Device: SensiumVitals wearable patch sensorImplementation of digital alerting sensor systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults admitted to general wards who will be staying at least 24h within hospital.
Key inclusion criteria (2 listed)
- Admitted adults on a general medical or surgical ward, identified as suitable by the clinical team.
- Able to provide written consent
Key exclusion criteria (4 listed)
- pacemaker/ICD
- open chest wound injury
- skin condition preventing sensor to be worn
- participant whom withdraws consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SensiumVitals wearable patch sensorWearable sensor which measures heart rate, respiratory rate, and temperature continuously. | Device | Post-implementation |
Primary outcome
Time to acknowledge alert
Time frame: through study completion, an average of 1 year
Time to acknowledge alert on mobile device/central monitoring station
4 secondary outcomes
Hospital length of stay
Time frame: through study completion, an average of 1 year
Mortality
Time frame: through study completion, an average of 1 year
Hospital readmissions
Time frame: through study completion, an average of 1 year
intensive care step up
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 35832414Iqbal 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.
- Derived from this study: PubMed 35794669Joshi 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.
- Derived from this study: PubMed 33944790Iqbal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meera Joshi, MRCS, PhD principal investigator
Honorary research fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Deterioration, Clinical, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahad M Iqbal, MBChB (hons) (02033326840, f.iqbal@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to acknowledge alert (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638738, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.