Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000034730
Ethics application status
Approved
Date submitted
10/12/2021
Date registered
17/01/2022
Date last updated
15/04/2024
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the impact of techniques and technologies on peripheral intravenous catheter insertion in children
Scientific title
Examining the impact of techniques and technologies on peripheral intravenous catheter insertion in children
Secondary ID [1] 306103 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TACTICS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral intravenous catheter failure 324420 0
Condition category
Condition code
Public Health 321918 321918 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients admitted to medical, surgical or critical care units, who require insertion of an intravenous catheter will be identified prospectively. All patients will have demographic data collected; e.g. admitting diagnosis, co-morbidities, skin and vein condition, PIVC insertion details. All participants will be invited to participate in the ultrasound sub study. Patients who consent to the ultrasound sub study will have an ultrasound assessment of the subcutaneous tissue, by a paediatric vascular access nurse practitioner, lasting approximately 5 min, and undertaken daily and until 48 hours post removal of PIVC.
Participants will be reviewed by a research nurse daily, until 48 hours post removal of PIVC. PIVCs inserted during patient admission will be eligible for recruitment. The research nurse will collect all PIVC risk factors for example: antibiotic type and dosage, flushing regime, continuous or intermittent intravenous fluid administration, dressing and other securement types, presence of 3-way tap. In addition device data such as catheter size, length, mobility status will also be collected.
Intervention code [1] 322270 0
Not applicable
Comparator / control treatment
Not applicable - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329661 0
First time PIVC insertion success - One skin puncture to achieve successful PIVC insertion as indicated by the ability to infuse 5-10mL 0.9% NaCl without resistance or evidence of external swelling at PIVC insertion site.
This data will be collected on insertion and verified in the patient electronic medical record.
Timepoint [1] 329661 0
At successful insertion of PIVC as demonstrated by successful infusion of fluid into the intravenous device without evidence of pain and or swelling
Secondary outcome [1] 404077 0
Number of attempts - Number of skin punctures required to insert device
This data will be collected on insertion by inserter (or observed by nurse or other personnel assisting at insertion) and verified in the patient electronic medical record.
Timepoint [1] 404077 0
At successful insertion of PIVC or abandonment of the procedure.
Secondary outcome [2] 404078 0
Time to insert device: from start of procedure (application of tourniquet), to successful insertion (instillation of 2-10mL (age appropriate) 0.9% NaCl without any swelling at the site and application of dressing). This will be documented at time of insertion by nurse assisting and documented in patient medical record
Timepoint [2] 404078 0
At successful insertion of PIVC
Secondary outcome [3] 404079 0
Pain, Assess using age appropriate scale
Face Legs Activity Cry and Consolability (FLACC) behavioural pain assessment tool in children with cognitive impairment and/or aged 0-5 years, Faces Pain Score (FPS) >5 years -8 years, Numeric rating scale >8years

This will be documented by nurse assisting procedure immediately or within 24 hours following successful PIVC insertion and documented in patient medical record.
Timepoint [3] 404079 0
Within 24 hours of successful PIVC insertion
Secondary outcome [4] 404080 0
Patient or parent reported satisfaction regarding insertion procedure (measured immediately following insertion using a 0-10 verbal rating scale)
Timepoint [4] 404080 0
Immediately following the successful insertion of PIVC or at conclusion of study participation.
Secondary outcome [5] 404081 0
Device dwell-time (time from insertion to removal, in hours) as recorded on purpose built data extraction form and patient medical records.
Timepoint [5] 404081 0
Collected at device removal
Secondary outcome [6] 404082 0
Vessel size as measured with ultrasound at insertion without tourniquet.
Timepoint [6] 404082 0
Prior to insertion attempt
Secondary outcome [7] 404083 0
Depth of vein as measured with ultrasound (as is usual practice during ultrasound guided PIVC insertion) from skin surface to superior wall of vein
Timepoint [7] 404083 0
Prior to insertion attempt
Secondary outcome [8] 404084 0
Post-insertion complication during dwell: PIVC dysfunction resulting in device no longer being suitable for treatment. A composite measure of causes of post-insertion complication including pain, infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis (pain, erythema), thrombosis (radiologically confirmed), dislodgement (complete or partial) or infection (laboratory confirmed local or primary bloodstream infection). This will be collected daily on purpose built data extraction form and obtained from patient medical records.
Timepoint [8] 404084 0
Collected daily during PIVC dwell
Secondary outcome [9] 404085 0
Post-insertion failure: PIVC dysfunction resulting in device no longer being suitable for treatment. A composite measure of causes of post-insertion failure including pain, infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis (pain, erythema), thrombosis (radiologically confirmed), dislodgement (complete or partial) or infection (laboratory confirmed local or primary bloodstream infection). This will be collected daily on purpose built data extraction form and obtained from patient medical records.
Timepoint [9] 404085 0
Collected at 48 hours following device removal
Secondary outcome [10] 404086 0
Length of PIVC within vein (measured with ultrasound, as is usual practice in ultrasound guided PIVC insertion, in milimetres) and documented on purpose built data extraction form and patient medical records.
Timepoint [10] 404086 0
At time of successful PIVC insertion
Secondary outcome [11] 404087 0
Vein size during dwell (measured in mm, with ultrasound in patients participating in the ultrasound sub study)
Timepoint [11] 404087 0
Measured during daily checks from PIVC insertion until PIVC removal
Secondary outcome [12] 404088 0
Measurement of subcutaneous oedema thickness in patients participating in the ultrasound sub study group (Distance between the posterior echogenic border of the dermis and the anterior echogenic border of the muscular fascia on Ultrasound images - measured in mm)
Timepoint [12] 404088 0
Measured during daily checks until PIVC removal
Secondary outcome [13] 404089 0
Presence of superficial venous thrombosis (Direct thrombus visualisation, Lack of compressibility, or Lack of colour flow)
Timepoint [13] 404089 0
During dwell on daily checks, until PIVC removal, and as documented on purpose built data collection form
Secondary outcome [14] 404090 0
Presence of oedema in patients participating in ultrasound sub study as indicated by cobblestone pattern on ultrasound
Timepoint [14] 404090 0
During dwell on daily checks until PIVC removal, and as documented on purpose built data collection form
Secondary outcome [15] 404091 0
Angle of tip lying within the vein lumen, as recorded on purpose built data extraction form and patient medical records.
Timepoint [15] 404091 0
During dwell on daily checks until PIVC removal, and as documented on purpose built data collection form
Secondary outcome [16] 404092 0
Angle of catheter on removal of all participants (curvature from hub to tip of catheter)
Timepoint [16] 404092 0
At removal of PIVC, and as documented on purpose built data collection form

Eligibility
Key inclusion criteria
All paediatric patients aged 0 - <18 years, admitted to the QCH and requiring insertion of a PIVC will be considered eligible for inclusion.
Minimum age
0 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children that are palliative, and/or PIVC in situ < 24 hours.
Children will be excluded from the ultrasound assessment component of the study if they are under the care of the department of communities and consent is not possible after attempting to contact the relevant case worker, or from a non-English speaking background without an interpreter.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The revised sample size (n=250) is based upon availability of PIVCs during the 12-month project period and to provide sufficient patients and necessary data to answer the research questions. Assuming a failure rate of 40%, this will provide 100 ‘cases’ for analysis. To support a regression analysis, it is suggested that “10 events per variable” are required. Therefore, assuming 100 ‘cases’ are available for analysis, this will provide for 10 pre-specified risk factors to be fitted to the data

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
30/11/2023
Actual
1/12/2023
Date of last data collection
Anticipated
9/12/2023
Actual
31/01/2024
Sample size
Target
250
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21310 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 36191 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 310223 0
Government body
Name [1] 310223 0
Health Innovation Investment Research Office
Country [1] 310223 0
Australia
Primary sponsor type
University
Name
University Of Queensland
Address
Sir Fred Schonell Drive St Lucia, QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 311320 0
Hospital
Name [1] 311320 0
Queensland Children's Hospital
Address [1] 311320 0
501 Stanley Street
South Brisbane Qld 4101
Australia
Country [1] 311320 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309907 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 309907 0
Ethics committee country [1] 309907 0
Australia
Date submitted for ethics approval [1] 309907 0
03/12/2021
Approval date [1] 309907 0
15/12/2021
Ethics approval number [1] 309907 0
HREC/21/QCHQ/81465

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115790 0
Ms Tricia Kleidon
Address 115790 0

Department of Anaesthesia and Pain Management
Level 7f, Queensland Children’s Hospital, Queensland
501 Stanley St, South Brisbane, Qld 4101
Country 115790 0
Australia
Phone 115790 0
+61 07 3068 1135
Fax 115790 0
Email 115790 0
[email protected]
Contact person for public queries
Name 115791 0
Tricia Kleidon
Address 115791 0

Department of Anaesthesia and Pain Management
Level 7f, Queensland Children’s Hospital, Queensland
501 Stanley St, South Brisbane, Qld 4101
Country 115791 0
Australia
Phone 115791 0
+61 07 3068 1135
Fax 115791 0
Email 115791 0
[email protected]
Contact person for scientific queries
Name 115792 0
Tricia Kleidon
Address 115792 0

Department of Anaesthesia and Pain Management
Level 7f, Queensland Children’s Hospital, Queensland
501 Stanley St, South Brisbane, Qld 4101
Country 115792 0
Australia
Phone 115792 0
+61 07 3068 1135
Fax 115792 0
Email 115792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant Data is Confidential


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
No additional documents have been identified.