Trauma Clinical Trial
— PRefillOfficial 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)
Verified date | May 2016 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Observational |
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).
Status | Completed |
Enrollment | 75 |
Est. completion date | May 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 15 Years |
Eligibility |
Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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 - Parents/carers (for the interview element of the study): - Unable to communicate despite translation services - Healthcare professionals (for the interview element of the study) |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham Univeristy Hospitals NHS Trust | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detect a 30% difference in measured CRT value between well children (PEWS <3, with normal perfusion) and unwell children (PEWS =3, with reduced perfusion). | Exit from study; Well patients within 1-2 hours; Unwell patients after leaving PICU average 3 days | No | |
Secondary | 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. | on completion of feedback, 30 minutes | No | |
Secondary | ii. Correlation of automated CRT results with vital cardiovascular clinical observations and tests - both invasive and non-invasive. | During study phase average 3 days | No | |
Secondary | iii. Correlation of automated CRT results with treatments supporting the cardiovascular and neurological system | during study phase average 3 days | No | |
Secondary | CRT in well compared with unwell patients | Grouped at end of study 12 months | No | |
Secondary | CRT changes with age and ethnicity in well children | grouped at end of study 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A |