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Trial registered on ANZCTR


Registration number
ACTRN12620000317998
Ethics application status
Approved
Date submitted
10/02/2020
Date registered
6/03/2020
Date last updated
26/10/2022
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.
Timepoint [1] 322794 0
Daily during study enrolment
Secondary outcome [1] 379816 0
Extravasation volume measured using surface area to limb length ratio, and 2D and 3D camera imaging.
Timepoint [1] 379816 0
Daily during study enrolment
Secondary outcome [2] 379817 0
Extravasation treatment sequelae, including count of number and types of dressings, scar management or skin grafting required, duration of treatment (including active scar management).
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 Brisbane Burns Scar Impact Profile.
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
Sex
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
Sample size calculations are based on the three-level outcome variable of extravasation severity (no, mild and moderate–severe). Local and international data report approximately 40% of PIVCs with intermediate-risk to high-risk infusates result in extravasation injuries in paediatrics under conditions similar to our ‘standard care’ scenario. In the control arm, we expect that 70% of patients will have severity ‘0’ (no), 25% will have severity ‘1’ (mild) and 5% will have severity >1 (moderate–severe). We expect in the ivWatch arm the equivalent probabilities will be 88%, 10.4% and 1.6%. This is equivalent to specifying a proportional OR of 0.32. With a=0.05 and power=90%, we are required to record outcome data on 96 participants in each group to detect a between-group difference of this size or greater. The proposed decrease in severity is conservative compared with the 78% relative decrease observed in previous cohort studies.
Patient characteristics will be summarised descriptively. Continuous data will be summarised as mean (SD) or median (25th–75th percentile) as appropriate. The primary outcome of extravasation severity will be investigated using ordinal logistic regression with treatment group included as the main effect. Secondary outcomes measured on an interval scale will be assessed using linear regression models, while binary outcomes will be assessed using logistic regression models and count outcomes will be assessed using Poisson regression models. In all regression models, treatment group will be included as the main effect, and the baseline value of the outcome will be included as a covariable if appropriate. Effect estimates will be reported with 95% CIs. Analyses will be conducted on an intention-to-treat basis. The cause of any missing data will be assessed, and sensitivity analyses to investigate their potential impact will be undertaken using multiple imputation techniques if appropriate. A per-protocol analysis will assess the effect of protocol violations (ie, ivWatch not applied). Statistical tests will be considered significant at the 95% level (p<0.05, two-tailed). For the economic assessment, the primary outcome is the incremental net monetary benefit of ivWatch compared with usual care and a secondary outcome of cost per reduction in extravasation injury severity. Primary analysis will be from the perspective of the healthcare sector. Healthcare costs 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. Estimates of the cost of healthcare utilisation associated with treatment of injury sequelae will be based on resource measurement collected within the trial. Subsequent reconstructive operations, such as skin grafting and/or scar revisional surgery, will be costed based on current treatment protocols and existing hospital cost estimates. Estimates of the 95% credible interval using non-parametric bootstrapping will be presented to characterise uncertainty in the economic outcomes. Qualitative interviews will be thematically analysed using standard techniques.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2020
Actual
9/09/2020
Date of last participant enrolment
Anticipated
28/04/2022
Actual
5/07/2022
Date of last data collection
Anticipated
30/04/2022
Actual
11/07/2022
Sample size
Target
200
Accrual to date
Final
182
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
Country [1] 304909 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Centre for Children's Health Research
62 Graham Street
South Brisbane 4101
QLD
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
Approved
Ethics committee name [1] 305318 0
The Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 305318 0
Ethics committee country [1] 305318 0
Australia
Date submitted for ethics approval [1] 305318 0
20/01/2020
Approval date [1] 305318 0
22/04/2020
Ethics approval number [1] 305318 0
HREC/20/QCHQ/60867
Ethics committee name [2] 308849 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 308849 0
Ethics committee country [2] 308849 0
Australia
Date submitted for ethics approval [2] 308849 0
22/04/2020
Approval date [2] 308849 0
07/05/2020
Ethics approval number [2] 308849 0
GU HREC (2020/310)
Ethics committee name [3] 311859 0
University of Queensland
Ethics committee address [3] 311859 0
Ethics committee country [3] 311859 0
Australia
Date submitted for ethics approval [3] 311859 0
09/03/2021
Approval date [3] 311859 0
12/03/2021
Ethics approval number [3] 311859 0
2021/HE000581

Summary
Brief summary
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
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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparing ivWatch biosensor to standard care to identify extravasation injuries in the paediatric intensive care: A protocol for a randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2020-047765
N.B. These documents automatically identified may not have been verified by the study sponsor.