SepticaemiaPRefillNCT02208817
The Paediatric Refill Study (PRefill)
An observational study of Septicaemia and Deformity of Spine, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies in recognising and managing sick children. Key recommendations from both reviews included the development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to better identify the sick or… Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Septicaemia, Deformity of Spine, Trauma
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to May 2016
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children will be recruited in The Queens Medical Centre, Nottingham University Hospitals NHS Trust, a teaching hospital, which has a paediatric intensive care unit (PICU).
Who may be able to join
- Children \& Young Adults
- Patients aged 1 month to 15 years with parental or legal guardian written informed consent.
- Patients groups:
- Patients who require PICU or high dependency care
- Matched controls who are well (PEWS<3)
- Must have a realistic prospect of survival
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- Parents/carers (for the interview element of the study):
- Parents/carers of children recruited into the PRefill study
- Healthcare professionals (for the interview element of the study):
- Healthcare professionals who have cared for a child with the device on
Who cannot join
- Children \& Young Adults
- Known pregnancy
- Underlying cardiac anomaly likely to affect perfusion,
- PEWS ≥3 (in matched well controls)
- Severe eczema/burns/other skin condition on site where CRT device needs to be positioned
- Known allergy to medical adhesive
Show all 10Show fewer
- Parents/carers (for the interview element of the study):
- Unable to communicate despite translation services
- Healthcare professionals (for the interview element of the study)
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Univeristy Hospitals NHS Trust
Nottingham, Nottinghamshire, NG72UH
About this study
Official title: Development of a Novel Paediatric Continuous Early Warning Monitor for the Children at Risk of Respiratory and Cardiovascular Collapse - The Paediatric Refill Study (PRefill)
2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies in recognising and managing sick children. Key recommendations from both reviews included the development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to better identify the sick or deteriorating child. PEWS tools offer the potential to identify and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of skin blood flow and is a vital part of many early warning and resuscitation scores. It is a sensitive marker of infection and dehydration in children. However, due to how it is performed and interpreted CRT is prone to marked variability between observers.
We have Medical Research Council (MRC) funding to develop an automated capillary refill device and user interface to provide a paediatric continuous early warning (PaedCEW) monitoring system. The PaedCEW system would complement and support current clinical practice and aim to address the difficulties of recognising ill children.
Read more
We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2 matched controls without significant illness from the Nottingham Children's Hospital. The 20 ill children will have their CRT (and PaedCEW score) monitored before, during and after admission to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations, lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status during periods of stability and compromise. Matched controls will be monitored for around 24 hours. This pilot study will allow development of our system.
This is a proof of concept study. This study aims to demonstrate a novel device for measuring CRT. Its correlation with noninvasive measures of cardiovascular status will enable a pragmatic comparison with current clinical practice. In addition, correlation with invasive measures of cardiovascular status will enable us to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).
Read the detailed description
Following recruitment, patients will have two devices placed on their skin, one on a limb (e.g. forearm), and one on their chest. They will be fixed to the skin using medical adhesive tape. The devices will be left on for around 1 hour on the "well patients" who are on a general paediatric ward. At the end of this time a member of the research team will remove the devices.
For patients going to the paediatric intensive care unit (PICU) the devices will be used to gather the CRT data before admission (where possible), during and following discharge from the PICU. The PICU participants will have the device left on during their stay, with the agreement of the clinical team caring for the patient, with the device being resited every 4-6 hours as is normal practice for medical devices attached to the skin. Data will be collected in this way during the PICU stay (which is typically 2-3 days) or until the patient is transferred to the general ward. Before they go home, these participants will be monitored again for up to an hour with the CRT devices to obtain data when they are well.
Collecting data in this way should allow us to show that our CRT device can detect a 30% difference in perfusion between the well and the unwell patient. By comparing well patient to unwell patient, and by comparing unwell patient, with themselves when well. For each participant we will collect routine demographic details, medical history details, Fitzpatrick skin colour assessment (that is their skin tone according to a recognised scale), height, weight and vital signs. Where taken, we will collect clinically relevant data in relation to the treatment received and results of clinical investigations for correlation with our device data. Patients on the PICU will have noninvasive measures of perfusion performed by the clinical team. The research team will also perform these at agreed times suitable to the care of the patient. This will include capillary refill and ultrasound assessment of blood flow (cardiac output).
We will also conduct a semistructured interview with the patient and/or their parents/carer at the time of the study to gain feedback on the device. This should take about 15 minutes and will take the form of a semistructured interview. We will also seek user (i.e. healthcare professionals) feedback on the device and the accompanying GUI using a semistructured interview (approximately 15 minutes).
- Conditions
- Septicaemia, Deformity of Spine, Trauma
- Keywords
- capillary refill, paediatric early warning score, photoplethysmography
- Medical subject headings
- Toxemia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ill patients | Ill patients who require Paediatric Intensive Care or Paediatric High Dependency Care | |
| Well Controls | Matched controls who are well (PEWS<3) | |
| Parent feedback | Feedback from parents/carers of children recruited into the PRefill study | |
| Healthcare professionals feedback | Feedback from healthcare professionals who have cared for a child with the device on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect a 30% difference in measured CRT value between well children (PEWS <3, with normal perfusion) and unwell children (PEWS ≥3, with reduced perfusion).
Measured: Exit from study; Well patients within 1-2 hours; Unwell patients after leaving PICU average 3 days
Secondary outcomes (5)
i.Feedback on acceptability of the device from patients, carers/parents, and healthcare professionals, and feedback on the graphical user interface (GUI) from healthcare professionals.
Measured: on completion of feedback, 30 minutes
ii. Correlation of automated CRT results with vital cardiovascular clinical observations and tests - both invasive and non-invasive.
Measured: During study phase average 3 days
iii. Correlation of automated CRT results with treatments supporting the cardiovascular and neurological system
Measured: during study phase average 3 days
CRT in well compared with unwell patients
Measured: Grouped at end of study 12 months
CRT changes with age and ethnicity in well children
Measured: grouped at end of study 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepticaemiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Don Sharkey, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208817
- Sponsor's protocol ID
- 14021
- Other IDs
- MRK0076101
- Acronym
- PRefill
- Status last verified
- May 2016
- First submitted
- 14 Jul 2014
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Paediatric Continuous Early Warning Monitor for the Children at Risk of Respiratory and Cardiovascular Collapse - The Paediatric Refill Study (PRefill)
- ClinicalTrials.gov ID
- NCT02208817
- Acronym / sponsor ID
- PRefill / 14021
- Conditions
- Septicaemia, Deformity of Spine, Trauma
- Keywords
- capillary refill, paediatric early warning score, photoplethysmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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.
2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies in recognising and managing sick children. Key recommendations from both reviews included the development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to better identify the sick or deteriorating child. PEWS tools offer the potential to identify and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of skin blood flow and is a vital part of many early warning and resuscitation scores. It is a sensitive marker of infection and dehydration in children. However, due to how it is performed and interpreted CRT is prone to marked variability between observers.
We have Medical Research Council (MRC) funding to develop an automated capillary refill device and user interface to provide a paediatric continuous early warning (PaedCEW) monitoring system. The PaedCEW system would complement and support current clinical practice and aim to address the difficulties of recognising ill children.
We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2 matched controls without significant illness from the Nottingham Children's Hospital. The 20 ill children will have their CRT (and PaedCEW score) monitored before, during and after admission to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations, lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status during periods of stability and compromise. Matched controls will be monitored for around 24 hours. This pilot study will allow development of our system.
This is a proof of concept study. This study aims to demonstrate a novel device for measuring CRT. Its correlation with noninvasive measures of cardiovascular status will enable a pragmatic comparison with current clinical practice. In addition, correlation with invasive measures of cardiovascular status will enable us to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).
Detailed description
Following recruitment, patients will have two devices placed on their skin, one on a limb (e.g. forearm), and one on their chest. They will be fixed to the skin using medical adhesive tape. The devices will be left on for around 1 hour on the "well patients" who are on a general paediatric ward. At the end of this time a member of the research team will remove the devices.
For patients going to the paediatric intensive care unit (PICU) the devices will be used to gather the CRT data before admission (where possible), during and following discharge from the PICU. The PICU participants will have the device left on during their stay, with the agreement of the clinical team caring for the patient, with the device being resited every 4-6 hours as is normal practice for medical devices attached to the skin. Data will be collected in this way during the PICU stay (which is typically 2-3 days) or until the patient is transferred to the general ward. Before they go home, these participants will be monitored again for up to an hour with the CRT devices to obtain data when they are well.
Collecting data in this way should allow us to show that our CRT device can detect a 30% difference in perfusion between the well and the unwell patient. By comparing well patient to unwell patient, and by comparing unwell patient, with themselves when well. For each participant we will collect routine demographic details, medical history details, Fitzpatrick skin colour assessment (that is their skin tone according to a recognised scale), height, weight and vital signs. Where taken, we will collect clinically relevant data in relation to the treatment received and results of clinical investigations for correlation with our device data. Patients on the PICU will have noninvasive measures of perfusion performed by the clinical team. The research team will also perform these at agreed times suitable to the care of the patient. This will include capillary refill and ultrasound assessment of blood flow (cardiac output).
We will also conduct a semistructured interview with the patient and/or their parents/carer at the time of the study to gain feedback on the device. This should take about 15 minutes and will take the form of a semistructured interview. We will also seek user (i.e. healthcare professionals) feedback on the device and the accompanying GUI using a semistructured interview (approximately 15 minutes).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ill patients | – | –Ill patients who require Paediatric Intensive Care or Paediatric High Dependency Care |
| Well Controls | – | –Matched controls who are well (PEWS<3) |
| Parent feedback | – | –Feedback from parents/carers of children recruited into the PRefill study |
| Healthcare professionals feedback | – | –Feedback from healthcare professionals who have cared for a child with the device on |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children will be recruited in The Queens Medical Centre, Nottingham University Hospitals NHS Trust, a teaching hospital, which has a paediatric intensive care unit (PICU).
Key inclusion criteria (10 listed)
- Children \& Young Adults
- Patients aged 1 month to 15 years with parental or legal guardian written informed consent.
- Patients groups:
- Patients who require PICU or high dependency care
- Matched controls who are well (PEWS<3)
Key exclusion criteria (10 listed)
- Children \& Young Adults
- Known pregnancy
- Underlying cardiac anomaly likely to affect perfusion,
- PEWS ≥3 (in matched well controls)
- Severe eczema/burns/other skin condition on site where CRT device needs to be positioned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect a 30% difference in measured CRT value between well children (PEWS <3, with normal perfusion) and unwell children (PEWS ≥3, with reduced perfusion).
Time frame: Exit from study; Well patients within 1-2 hours; Unwell patients after leaving PICU average 3 days
5 secondary outcomes
i.Feedback on acceptability of the device from patients, carers/parents, and healthcare professionals, and feedback on the graphical user interface (GUI) from healthcare professionals.
Time frame: on completion of feedback, 30 minutes
ii. Correlation of automated CRT results with vital cardiovascular clinical observations and tests - both invasive and non-invasive.
Time frame: During study phase average 3 days
iii. Correlation of automated CRT results with treatments supporting the cardiovascular and neurological system
Time frame: during study phase average 3 days
CRT in well compared with unwell patients
Time frame: Grouped at end of study 12 months
CRT changes with age and ethnicity in well children
Time frame: grouped at end of study 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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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.
Don Sharkey, PhD principal investigator
University of Nottingham
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 Septicaemia and Deformity of Spine, run by University of Nottingham 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 19 May 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect a 30% difference in measured CRT value between well children (PEWS <3, with normal perfusion) and unwell children (PEWS ≥3, with reduced perfusion). (time frame: Exit from study; Well patients within 1-2 hours; Unwell patients after leaving PICU average 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2016.