Condition category
Not Applicable
Date applied
20/09/2012
Date assigned
06/11/2012
Last edited
16/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
To help doctors and nurses recognise when patients are becoming unwell, they are monitored in hospital by an Early Warning System called ‘Track & Trigger’. Each time clinical measurements (for example pulse, blood pressure, temperature and the body’s oxygen levels) are recorded, they are compared to a scale and given a number that represents the position on the scale. If the number is too high, the nurse at the bedside will respond by asking for help from a doctor or more senior nurse. Everyone is compared against the same scale and we do not know if this is the best way to monitor patients during their hospital stay. This study is designed to investigate whether it is possible to create a personalised monitoring programme for patients who are discharged from the Intensive Care Unit.
The aim of the study is to link information from a patient’s stay in the intensive care unit with measurements taken during their hospital stay after discharge from intensive care. We will use this information to programme an automatic alerting calculation that will be different for each patient. We want to test whether this new system will improve nurses’ and doctors’ abilities to watch over patients and if it might also alert them earlier to a patient who may be in need of more treatment, a different type of care, or more or less monitoring.

Who can participate?
Patients who are being discharged from the intensive care units at the Oxford University Hospitals NHS Trust and the Royal Berkshire NHS Foundation Trust.

What does the study involve?
Before patients leave the intensive care unit, or shortly after they arrival on their new ward, the study monitoring equipment will be attached to them. This involves attaching some sticky dots to their chest which will connect leads from the patient to the monitor so that their heart rate can be recorded. Patients will also be asked to wear a device that will measure the levels of oxygen in their blood.
Patients in the study will be visited by research nurses once or twice each day while they are wearing the monitoring equipment. The nurses will check that it is recording correctly and that there are no problems. They will also look at the patient’s medical notes and will record information about them and the treatment they are given during their hospital stay. Patients will be asked to wear the monitor until they are discharged from hospital. However, if they are still in hospital fourteen days after they have been discharged from the intensive care unit, we will remove the monitor.

What are the possible benefits and risks of participating?
This study may help us in the future to improve the standard of care for patients who are at risk of developing health problems after their stay in the intensive care unit. We hope that the information we collect from patients about their stay in hospital will allow us to treat future patients faster and perhaps save lives. There are no known risks associated with taking part in this trial.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
The study started in October 2012 and is expected to end in September 2014. The first patient will be recruited before the end of 2012.

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Ms Julie Darbyshire
picram@ndcn.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Julie Darbyshire

ORCID ID

Contact details

University of Oxford
Kadoorie Centre for Critical Care Research
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
-
picram@ndcn.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12730

Study information

Scientific title

Post-Intensive Care Risk-adjusted Alerting and Monitoring - an observational study

Acronym

PICRAM 2

Study hypothesis

Patients discharged from intensive care units (ICU) have a very high risk of subsequently deteriorating on hospital wards. PICRAM will develop ways of alerting clinicians to these deteriorations early. After ICU discharge, there is little information available about the normal course which patients’ vital signs follow if they are safely discharged from hospital. Using an ambulatory monitor we plan to continuously record vital signs from up to 500 patients who have spent more than three days in ICU from 2 hospitals (one teaching hospital – Oxford University Hospitals NHS Trust one large district general hospital – The Royal Berkshire NHS Trust). We will also recover vital signs from the 72 hours leading up to discharge from the ICU, (recorded in the standard clinical electronic database). These two sets of data will allow us to understand the patterns by which patient recovery is displayed in vital signs. We will develop ways by which clinicians can be alerted to patients who are not following these patterns of recovery, as these patients will be at greater risk of deterioration. Finally, we will recover data from the patient’s ICU stay. We have developed a large anonymised database from the standard clinical electronic databases of the two Intensive Care Units. We are using this to design tools to help clinicians recognise which patients are at risk of deterioration after discharge from intensive care. We will use data from the Intensive Care Unit stay of the patients whose vital signs we record after intensive care discharge to work out how best to merge the data from their time in Intensive Care with the vital signs recovery patterns to best identify patients who are deteriorating after ICU discharge.

The use of prolonged ambulatory vital sign monitoring in post-intensive care patients is relatively novel. We will therefore record patients’ views on the wearability of the system and data on the functionality of the system.

Ethics approval

Oxford C Research Ethics Committee, 16/10/2012, ref: 12\SC\0357

Study design

Non-randomised observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact picram@ndcn.ox.ac.uk to request a patient information sheet

Condition

Critical care

Intervention

Before patients leave the intensive care unit, or shortly after they arrival on their new ward, the study monitoring equipment will be attached to them. This involves attaching some sticky dots to their chest which will connect leads from the patient to the monitor so that their heart rate can be recorded. Patients will also be asked to wear a device that will measure the levels of oxygen in their blood.
Patients in the study will be visited by research nurses once or twice each day while they are wearing the monitoring equipment. The nurses will check that it is recording correctly and that there are no problems. They will also look at the patient’s medical notes and will record information about them and the treatment they are given during their hospital stay.
Patients will be asked to wear the monitor until they are discharged from hospital. However, if they are still in hospital fourteen days after they have been discharged from the intensive care unit, we will remove the monitor.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To collect a large dataset containing physiological data on patients

Secondary outcome measures

To demonstrate the feasibility of using commercially available

Overall trial start date

01/10/2012

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Aged 16 years or above
3. Discharged from adult intensive care unit.
4. Male and female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 500

Participant exclusion criteria

1. Patients discharged for palliative care
2. Patients whose anatomy, condition or prior surgery precludes the use of the wearable monitoring equipment
3. Patients who cannot understand written English and for whom no translator can be found
4. Patients not able to give informed consent due to diminished capacity

Recruitment start date

01/10/2012

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Cancer Therapeutics Research Group (CTRG)
Joint Research Office
Block 60 Churchill Hospital
Headington
OX3 7LJ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Research organisation

Funder name

Wellcome Trust ref: HICF-0510-006

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/11/2016: No publications found, verifying study status with principal investigator.