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Trial registered on ANZCTR


Registration number
ACTRN12620000317998p
Ethics application status
Submitted, not yet approved
Date submitted
10/02/2020
Date registered
6/03/2020
Date last updated
6/03/2020
Date data sharing statement initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Early detection of extravasation injuries in children with critical illness
Scientific title
Comparing ivWatch® to standard care to identify extravasation injuries in the Paediatric Intensive Care: an efficacy trial
Secondary ID [1] 300491 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PICU ivWatch®
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extravasation injuries 316172 0
Condition category
Condition code
Injuries and Accidents 314464 314464 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: ivWatch®
One hundred patients admitted to a Paediatric Intensive Care Unit (PICU) with a peripheral intravenous access device (PIVC) receiving intermediate to high risk infusates and randomised to the ivWatch intervention arm will be provided with the ivWatch® device.

The ivWatch® device consists of a sensor ~2 cm in diameter that is attached to the patient’s skin with an adhesive receptacle as close as possible to the centre of the PIVC site (approximately 1 cm), and covered with gauze. The sensor connects to the ivWatch® monitor via a cable. The ivWatch® device will be applied by member of the research team (a Clinical Research Nurse), and monitored hourly by the patient’s bedside nurse throughout the course of their PICU admission or until their PIVC is removed. The patient’s bedside nurse will also continue to monitor the PIVC site hourly for signs of extravasation (per usual, routine clinical practice) in addition to monitoring the ivWatch® patient monitor. All other aspects of PIVC insertion, management and removal will be standardised in accordance with QCH clinical practice guidelines. Insertion, maintenance and removal will be performed by the usual PICU interdisciplinary staff.

The ivWatch® device consists of:
1. A patient monitor,
2. An optical sensor cable, and,
3. A sterile, disposable receptacle for attaching the sensor to the patient’s skin, near the PIVC site

The ivWatch® uses near infra-red light to continuously monitor the fluid pathway and surrounding tissue for early signs of extravasation. When fluid accumulates in the subcutaneous tissues, there is a significant change in the light scattering, which is recognised by ivWatch® sensor and results in a “YELLOW CHECK IV” notification on the patient monitor, indicating the possibility of extravasation. If the infusion continues and the light signal further drops below the threshold, the patient monitor will return a “RED CHECK IV” notification, indicating probable extravasation.

According to the ivWatch® manufacturers, the algorithm used to process the light signal from the sensor is designed to maximize sensitivity and specificity for infiltration events, while minimizing the number of false alarms from other events (e.g., patient movement).
Intervention code [1] 316800 0
Early detection / Screening
Intervention code [2] 316801 0
Prevention
Comparator / control treatment
One hundred patients admitted to a Paediatric Intensive Care Unit (PICU) with a peripheral intravenous access device (PIVC) receiving intermediate to high risk infusates will continue to receive usual, routine clinical practice: monitoring of the PIVC site for signs of extravasation by their bedside nurse.
Control group
Active

Outcomes
Primary outcome [1] 322794 0
Extravasation injury severity, described using the Cincinnati Children’s Extravasation HARM, the Infusion Nurses Society Grading and 3D camera imaging
Timepoint [1] 322794 0
Daily during study enrolment
Secondary outcome [1] 379816 0
Extravasation volume measured using surface area to limb length ratio
Timepoint [1] 379816 0
Daily during study enrolment
Secondary outcome [2] 379817 0
Extravasation treatment sequelae, including scar management, described using the Cincinnati Children’s Extravasation HARM and the Infusion Nurses Society Grading
Timepoint [2] 379817 0
At PICU discharge and study completion
Secondary outcome [3] 379818 0
Number of PIVCs used per patient assessed using a study-specific questionnaire and data-linkage to medical records
Timepoint [3] 379818 0
At PICU discharge
Secondary outcome [4] 379819 0
PIVC dwell-time measured by the interval of time (hours and minutes) between the date and time the PIVC is inserted and removed, recorded in a study-specific questionnaire.
Timepoint [4] 379819 0
At PICU discharge
Secondary outcome [5] 379820 0
Quality of life, measured using the Child Health Utility Index (CHU9D)
Timepoint [5] 379820 0
At PICU discharge
Secondary outcome [6] 379821 0
Healthcare costs, including costs of ivWatch®, additional PIVCs, extravasation and sequelae, hospital length of stay. These data will be collected using a combination of individual patient assessment, Medicare data and study-specific questionnaires.
Timepoint [6] 379821 0
At PICU discharge and study completion
Secondary outcome [7] 379822 0
Feasibility, based on the following criteria:
1. Eligibility (% of all new admissions to PICU screened who meet all inclusion and no exclusion criteria);
2. Recruitment (% of eligible patients providing informed consent);
3. Retention (% of recruited patients lost to follow up or withdrawing consent);
4. Protocol fidelity (% of randomised patients receiving their allocated intervention);
5. Missing data (% of total data unable to be collected);
6. Effect estimates for sample size calculation for larger RCT
Timepoint [7] 379822 0
At study completion
Secondary outcome [8] 379823 0
Acceptability of the ivWatch® device, measured through semi-structured interviews with participant family members and clinicians.
Timepoint [8] 379823 0
At patient discharge (family) and study completion (clinicians)

Eligibility
Key inclusion criteria
PIVC anticipated to be in situ for > 24 hours;
Patient anticipated to be admitted to PICU for >24 hours; and,
Planned administration of one or more intermediate to high risk infusates (as defined by Clark et al. (2013)), via the study PIVC. This includes intermediate [e.g., phenytoin, vancomycin, midazolam, morphine] and high-risk drugs [e.g., vasopressors, calcium, acyclovir, mannitol]).
Minimum age
No limit
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous participation in the ivWatch® study (i.e., previously enrolled in this study and randomized to one of the treatment conditions)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed randomisation will be performed using RedCap by someone external to the project team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be web based in a 1:1 single block ratio. Block sizes will be either 8 or 10 (size randomly selected).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Local and international data report approximately 40% of PIVCs with intermediate to high risk infusates result in extravasation injuries in paediatrics under conditions similar to our ‘standard care’ scenario. A sample of n = 200 (that is, 100 in each of the treatment groups) will give >80% power to detect an extravasation injury percentage of 21% or less in the intervention group (two-sided alpha=0.05). This 47.5% relative decrease is conservative compared with the 78% relative decrease observed in a similar trial evaluating the ivWatch® device.

Data analysis will be conducted using: descriptive statistics to summarise feasibility criteria and patient characteristics, using appropriate measures of spread and locations; and comparisons between study arms on extravasation severity via Fishers Exact Test. For the economic assessment, a cost per extravasation injury by injury severity type will be estimated based on current treatment protocols. The total cost per injury will be derived as the sum product of healthcare resources and their respective price including labour time, consumables, medication, and length of stay. In addition, the total cost per ivWatch® including associated training, maintenance and other costs will be reported. All estimates will be reported as a mean and standard deviation, or as a median and interquartile range (IQR) for non-normally distributed data. Qualitative interviews with patients, family and clinicians will be thematically analysed, using standard techniques.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15818 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 29254 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304909 0
Charities/Societies/Foundations
Name [1] 304909 0
Children's Hospital Foundation
Address [1] 304909 0
494 Stanley St, South Brisbane QLD 4101
Country [1] 304909 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University, 170 Kessels Rd, Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 305252 0
None
Name [1] 305252 0
Address [1] 305252 0
Country [1] 305252 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305318 0
The Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 305318 0
Centre for Children’s Health Research, Queensland Children’s Hospital Precinct, Level 7, 62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 305318 0
Australia
Date submitted for ethics approval [1] 305318 0
20/01/2020
Approval date [1] 305318 0
Ethics approval number [1] 305318 0

Summary
Brief summary
Peripheral intravenous catheters (PIVCs) are small hollow tubes inserted into veins for medical therapy in most children admitted to a Paediatric Intensive Care Unit (PICU). However, extravasation or ‘leaking’ of fluid into surrounding tissues remains a harmful complication. Nursing surveillance and assessment of PIVCs assists in detection of extravasation. However, demanding clinician workloads and the inability of some patients to communicate symptoms during critical illness has proved early detection challenging. In order to improve early detection of extravasation injuries, ivWatch® was developed as continuous and non-invasive monitor of PIVCs. It consists of a patient monitor, an optical sensor cable, and a sterile, disposable receptacle for attaching the sensor to the patient’s skin, near the PIVC site. Using infrared light, ivWatch® manufacturers claim the device can detect early signs of extravasation. However, there are few clinical data regarding the effectiveness, acceptability and value of ivWatch®. We are undertaking an efficacy trial to test the feasibility of a larger trial to evaluate the effectiveness of ivWatch®, versus surveillance by clinicians, to identify extravasations within the PICU. We believe this technology has the potential to significantly improve treatment provision and increase patient safety within all critical care settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99978 0
A/Prof Craig McBride
Address 99978 0
Queensland Children’s Hospital
501 Stanley St, South Brisbane QLD 4101
Country 99978 0
Australia
Phone 99978 0
+61 7 3068 1111
Fax 99978 0
Email 99978 0
craig.mcbride@health.qld.gov.au
Contact person for public queries
Name 99979 0
A/Prof Craig McBride
Address 99979 0
Queensland Children’s Hospital
501 Stanley St, South Brisbane QLD 4101
Country 99979 0
Australia
Phone 99979 0
+61 7 3068 1111
Fax 99979 0
Email 99979 0
craig.mcbride@health.qld.gov.au
Contact person for scientific queries
Name 99980 0
A/Prof Craig McBride
Address 99980 0
Queensland Children’s Hospital
501 Stanley St, South Brisbane QLD 4101
Country 99980 0
Australia
Phone 99980 0
+61 7 3068 1111
Fax 99980 0
Email 99980 0
craig.mcbride@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results