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Trial registered on ANZCTR


Registration number
ACTRN12623000561684
Ethics application status
Approved
Date submitted
18/04/2023
Date registered
25/05/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing infusate injuries throughout a child’s hospitalisation
Scientific title
Assessing the impact of an intravenous biosensor on the prevention of infusate injuries throughout a child’s hospitalisation: A Type 1 Hybrid Randomised Controlled Trial
Secondary ID [1] 309480 0
NH&MRC Funding ID: MRF2022095
Universal Trial Number (UTN)
Trial acronym
PATCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extravasation injuries (caused by peripheral intravenous catheters of infants) 329745 0
Condition category
Condition code
Injuries and Accidents 326649 326649 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The IV biosensor (ivWatch® sensor applied within 10–15mm of the peripheral intravenous catheter (PIVC) tip) plus standard clinical observation to detect extravasations and prevent extravasation injury.
The IV biosensor device consists of:
1. A patient monitor with audible alarm,
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 IV biosensor involves the blue sensor being placed over tissue / polyurethane dressing next to the vein between the intravenous (IV) insertion site and the IV tip (normally around 5-10mm from the insertion site) and plugged into the monitor.
Once applied, this sensor stays in situ until study end (i.e. IV removal or discharge from study hospital), unless the infant needs magnetic resonance imaging (MRI; due to metal in the sensor) or other treatments which are incompatible with the IV biosensor. The IV biosensor is to be applied on the day of enrolment for both newly inserted PIVCs and existing PIVCs.
The IV biosensor 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 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, standard clinical practice) in addition to monitoring the IV biosensor patient monitor. All other aspects of PIVC insertion, management and removal will be standardised in accordance with the hospital site’s clinical practice guidelines. Insertion, maintenance and removal will be performed by the usual interdisciplinary staff. The Clinical Research Nurse will monitor and record adherence to the protocol during a daily check.

The IV biosensor 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 the IV biosensor 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.
Intervention code [1] 325907 0
Early detection / Screening
Intervention code [2] 325908 0
Prevention
Intervention code [3] 326013 0
Treatment: Devices
Comparator / control treatment
Standard clinical observation: Standard care will involve visual assessment and documentation of the site hourly for signs of extravasation by clinicians, as per each sites' hospital protocol.
Control group
Active

Outcomes
Primary outcome [1] 334509 0
The primary outcome is any extravasation injury measured using the 4-point Cincinnati Children’s Hospital Medical Centre (CCHMC) Extravasation Harm Scale.
Measurement is binary - no harm OR mild, moderate or severe harm.
Timepoint [1] 334509 0
Daily during study enrolment and PIVC use.
Secondary outcome [1] 420943 0
Extravasation volume: measured as a composite value and a proportion using arms length as an estimate of a patient's size. This equation is the length of the widest point on the swollen extravasation area divided by the length of the arm from the axila to finger tips x 100 to give a percentage. 2D and 3D camera imaging (including comparison to non-affected limb) will be used as verification sources.
Timepoint [1] 420943 0
Measurements made first within 24 hours of extravasation injury occurrence and repeated daily until the extravasation injury has stabilised. The largest volume will be used.
Secondary outcome [2] 420944 0
Quality of Life, measured by the Brisbane Burns Scar Impact Profile (<8 years; including modifications for extravasation injuries)
Timepoint [2] 420944 0
Post extravasation injury. Daily until injury stabilises and then at 1, 3 and 6 months post hospital discharge
Secondary outcome [3] 420945 0
EuroQol Five Dimension multi-attribute utility instrument (EQ-5D-Y, Australian version) is brief self-reported generic measure of current health with a visual analogue scale from 1-100.
It also includes five questions on dimensions (mobility, self care, usual activities, pain and discomfort, anxiety) which are scored with a 3 point Likert scale on the level of functioning.
Timepoint [3] 420945 0
Measured at Recruitment, at study completion (removal of PIVC) and if there is an extravasation injury then again at 1, 3 and 6 months post hospital discharge.
Secondary outcome [4] 420946 0
Extravasation treatment sequelae,
1) Surgical Intervention required (Y/N) and type of procedure (skin graft, debridement, fasciotomy, surgical cleaning, surgical excision, exudate removal, surgical puncture), This data will be gathered from the medical record.
Timepoint [4] 420946 0
Censored at 6 months post extravasation injury. Measurements taken once at extravasation then daily until the injury stabilises and again at 3 time points post discharge at 1, 3 and 6 months.
Secondary outcome [5] 420947 0
Extravasation injury colour changes, as measured by the metric graduated colour (MGC) tool from the patient directly. The tool contains a range of 15 colours.
The MGC tool represents colours unique to skin assessment, various skin tones, skin injury phases and to changes of skin colour unique to neonatal population due to skin maturation following birth.
Timepoint [5] 420947 0
Measurements made first within 24 hours of extravasation injury occurrence and repeated daily until the extravasation injury has stabilised.
Secondary outcome [6] 420948 0
Requirement for replacement IV collected from clinical records
Timepoint [6] 420948 0
At removal of IV biosensor within hospital
Secondary outcome [7] 420949 0
Peripheral IV dwell time, measured in hours calculated from insertion and removal times collected from clinical records.
Timepoint [7] 420949 0
During peripheral intravenous catheter use
Secondary outcome [8] 420952 0
Near infra-red / heat related skin injuries, at the PIVC site. (yes/no). This data will be gathered from the medical record.
Timepoint [8] 420952 0
Daily during study enrolment following PIVC use
Secondary outcome [9] 420953 0
Device related mechanical injuries surrounding the IV site. Injuries will be classified as mechanical adhesive related (yes/no) or pressure injuries (using the National Pressure Ulcer Advisory Panel numerical stage system - Stages 1-4, deep tissue or unstageable). This data will be gathered from the medical record.
Timepoint [9] 420953 0
Daily during study enrolment following PIVC use
Secondary outcome [10] 420954 0
Cost, including quantifying additional costs of the intervention (including staff wage costs for application, troubleshooting, replacement, consultation, and equipment used will be recorded), cost offsets (considering extravasations, reinsertions and treatment costs of extravasation per group) and net monetary benefit,
This outcome will be determined by observing clinical practice for the management of complications, review of medical records, and consolidated via approximation of direct costs (via hospital purchasing departments).
Timepoint [10] 420954 0
From recruitment until discharge and study completion.
Secondary outcome [11] 421491 0
Extravasation injury pH as measured by non-invasive pH meter monitors from the patient directly.
Timepoint [11] 421491 0
Measurements made first within 24 hours of extravasation injury occurrence and repeated daily until the extravasation injury has stabilised.
Secondary outcome [12] 421826 0
Extravasation treatment sequelae,
2) Medical Intervention required (Y/N) and type of drug (hyaluronic acid, hyaluronidase, antibiotics). This data will be gathered from the medical record.
Timepoint [12] 421826 0
Censored at 6 months post extravasation injury. Measurements taken once at extravasation then daily until the injury stabilises and again at 3 time points post discharge at 1, 3 and 6 months.
Secondary outcome [13] 421827 0
Extravasation treatment sequelae,
3) Dressing Intervention required (Y/N) and type of dressing (options of simple, vacuum-based, medicated). This data will be gathered from the medical record.
Timepoint [13] 421827 0
Censored at 6 months post extravasation injury. Measurements taken once at extravasation then daily until the injury stabilises and again at 3 time points post discharge at 1, 3 and 6 months.
Secondary outcome [14] 421828 0
Extravasation treatment sequelae,
4) First aid only required (Y/N) and type of action performed (only requiring removal of IV, elevation, compression, cold pack, and equivalent). This data will be gathered from the medical record.
Timepoint [14] 421828 0
Censored at 6 months post extravasation injury. Measurements taken once at extravasation then daily until the injury stabilises and again at 3 time points post discharge at 1, 3 and 6 months.

Eligibility
Key inclusion criteria
1) Neonates (greater than or equal to 1250 grams + physically able to fit the IV sensor on the limb)

2) Infants younger than one year

3) Have an existing or new peripheral IVs (including long and traditional peripheral IV) inserted in the distal half of a limb (i.e. proximal to antecubital for upper limb).

4) Peripheral IV anticipated to be in situ for >24 hours,

5) Planned administration via the study peripheral IV of either:
-continuous fluids (for 4 hours or more) including blood products.
-antimicrobials, or
-intermediate to high risk infusates .
Minimum age
No limit
Maximum age
1 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Planned administration of lipid-based infusate via study peripheral IV (e.g., propofol).

2) Other types of vascular access devices, including midline catheters, peripheral arterial catheters and central venous catheters

3) Pre-existing skin condition effecting study peripheral IV site, e,g., i) atopic dermatitis or extensive erythema toxicum, ii) infectious diseases such as Staphylococcal scalded skin syndrome; iii) burn (e.g., heat, decontamination); iv) inherited conditions such as epidermolysis bullosa, ichthyosis and aplasia cutis congenita

4) Previously enrolled in this study and randomized to one of the treatment conditions

5) Currently receiving end of life and/or redirection of care.

Study design
Purpose of the study
Prevention
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)
Patients will be randomised via a web based system, with 1:1 ratio between groups, with randomly varied block sizes (6 to 8) and stratification by site and pre- vs post-term age.
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
This is a Type-1 hybrid effectiveness implementation RCT. A 2-arm, superiority, effectiveness RCT will compare the effectiveness of the IV biosensor with standard observation, to detect extravasations and prevent extravasation injury. Concurrently, a mixed methods study will assess the uptake and attitudinal barriers and facilitators for implementation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on binary expression of extravasation (no harm vs mild, moderate, severe). We conservatively estimate 20% of standard care alone participants will develop any extravasation injury (either mild, moderate, severe) and expect 10% of IV biosensor will develop an extravasation injury. That is, we expect the IV biosensor to have a 50% relative risk reduction in extravasation, compared to standard observation alone. With a=0.05 and power=90%, we are required to record outcome data on 266 participants in each group to detect a between-group difference of this size or greater (total sample=532).
The primary analyses will compare between-groups using a binary logistic regression model with treatment group (IV biosensor + standard observation/standard observation alone) entered as the main effect. Effect estimates will be presented as odds ratio and 95% CI. Secondary outcomes will be analysed using linear regression (continuous data), logistic regression (binary data) or Poisson regression (count data) as appropriate. The cause of any missing data will be assessed, and sensitivity analyses to investigate the potential impact of missingness will be undertaken using multiple imputation techniques if appropriate. Analysis will be ‘intention to treat’ with IVs the unit of measurement (one IV per child only). A per-protocol analysis will assess the effect of protocol violations (i.e. non-randomised IV biosensor). p-values =0.05 will be considered significant.

Estimating cost effectiveness
Regression analysis of the total cost per patient as the dependent variable will be conducted using a generalised linear model with trial group allocation as the predictive variable and controlling possible confounders. A gamma family, log-link model has been assumed given the typically skewed nature of health cost data but will be further tested for appropriate model specification. Cost-utility analysis will be carried out and either the incremental cost per quality adjusted life year gained or net monetary benefit will be calculated based on commonly accepted threshold values of a quality adjusted life year. Probabilistic sensitivity analysis will be used to characterise uncertainty in parameters of the economic evaluation and presented using both a scatter plot and cost-effectiveness acceptability curve. Particular consideration will be given to the potential for cost effectiveness to vary by patient, treatment and other characteristics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
13/11/2023
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
532
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24553 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 24554 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 24555 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 40148 0
4029 - Herston
Recruitment postcode(s) [2] 40147 0
4101 - South Brisbane
Recruitment postcode(s) [3] 40149 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 313676 0
Government body
Name [1] 313676 0
National Health and Medical Research Council - MRFF
Country [1] 313676 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Queensland
ST LUCIA QLD 4072
Country
Australia
Secondary sponsor category [1] 315477 0
None
Name [1] 315477 0
Address [1] 315477 0
Country [1] 315477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312841 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 312841 0
Level 7, Centre for Children’s Health Research 62 Graham St
South Brisbane, Queensland 4101
Ethics committee country [1] 312841 0
Australia
Date submitted for ethics approval [1] 312841 0
17/04/2023
Approval date [1] 312841 0
24/05/2023
Ethics approval number [1] 312841 0
HREC/23/QCHQ/95263

Summary
Brief summary
Many babies and infants admitted to hospital need fluids or medicines delivered directly into their veins using an intravenous (IV) catheter. Over time, IV's can dislodge from the veins and some cases, the medicine or fluid can leak into the child's tissue around the vein, causing damage to the skin, tissue and the vein itself. This is called an extravasation injury. An early sign of extravasation injury is pain, however babies and infants cannot always communicate that the IV site is painful making early detection painful. The IV biosensor is a new device that may help detect extravasation injury sooner. A biosensor is a special light similar to an oxygen saturation probe that is placed on the child's skin above the IV site. It uses near infra-red light to scan the tissues to detect extravasation injury and alerts clinicians so the infusion can be stopped to limit damage caused to the surrounding tissue. This trial will examine whether the IV biosensor helps to detect extravasation injury in babies and infants earlier than compared to standard care. It will also assess whether it is safe and easy to use, and whether it decreases the severity of extravasation injuries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126106 0
Prof Amanda Ullman
Address 126106 0
Level 7, Centre for Children’s Health Research 62 Graham St
South Brisbane, Queensland 4101
Country 126106 0
Australia
Phone 126106 0
+61 7 30697238
Fax 126106 0
Email 126106 0
a.ullman@uq.edu.au
Contact person for public queries
Name 126107 0
Prof Amanda Ullman
Address 126107 0
Level 7, Centre for Children’s Health Research 62 Graham St
South Brisbane, Queensland 4101
Country 126107 0
Australia
Phone 126107 0
+61 7 30697238
Fax 126107 0
Email 126107 0
a.ullman@uq.edu.au
Contact person for scientific queries
Name 126108 0
Prof Amanda Ullman
Address 126108 0
Level 7, Centre for Children’s Health Research 62 Graham St
South Brisbane, Queensland 4101
Country 126108 0
Australia
Phone 126108 0
+61 7 30697238
Fax 126108 0
Email 126108 0
a.ullman@uq.edu.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

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No documents have been uploaded by study researchers.

Documents added automatically
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