Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001424392
Ethics application status
Approved
Date submitted
3/10/2017
Date registered
9/10/2017
Date last updated
20/03/2019
Date data sharing statement initially provided
20/03/2019
Date results provided
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of Extended Peripherally-Inserted Catheters and Their Utility in Children Undergoing Surgery
Scientific title
A Clinical Trial to Evaluate the Safety and Utility of Extended Peripherally-Inserted Catheters (EPIC) in Paediatric Surgery
Secondary ID [1] 292853 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous access after surgery in children. 304956 0
Condition category
Condition code
Surgery 304288 304288 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: EPIC group
The EPIC group will receive a 22G 8cm long catheter, inserted by a paediatric anaesthetist in theatre after completion of the relevant surgical procedure. Catheters will be inserted into a peripheral vein of the upper arm or forearm, and remain in situ for for the duration of treatment, catheter failure, or up to 30 days (as recommended by the manufacturer).
Intervention code [1] 299096 0
Treatment: Devices
Comparator / control treatment
Control: PC group
The PC group will receive standard IV cannulae, sized according to the judgement of the anaesthetic team, and will be managed as per routine hospital policy. Cannulae will be inserted in the forearm or hand, and remain in situ till failure, or up to 3 days.
Control group
Active

Outcomes
Primary outcome [1] 303335 0
Phlebitis will be assessed using a validated score system:

Score Clinical Signs

0 No clinical symptoms

1 Erythema ± oedema
No palpable cord
No streak formation

2 Erythema ± oedema
Streak formation
No palpable cord

3 Erythema ± oedema
Streak formation
Palpable cord
Timepoint [1] 303335 0
Date of insertion to date of discharge from hospital
Primary outcome [2] 303581 0
Occlusion - Blockage of the IV line
This will be assessed by the treating nurse and the investigator and confirmed by the inability to flush the IV line.
Timepoint [2] 303581 0
Date of insertion to date of discharge from hospital
Primary outcome [3] 303582 0
Dislodgement
This will be assessed by the treating nurse and the investigator and confirmed by the presence of the IV line tip outside the peripheral vein.
Timepoint [3] 303582 0
Date of insertion to date of discharge from hospital
Secondary outcome [1] 338669 0
Primary outcome
Extravasation
This will be assessed by a validated extravasation score:
Score Clinical Criteria

0 No symptoms

1 Skin blanched
Edema< 1 inch in any direction
Cool to touch
With or without pa.in

2 Skin blanched
Edema 1-6 inches in any direction
Cool to touch
With or without pain

3 Skin blanched, translucent
Gross edema >6 inches in any direction
Cool to touch
Mild-moderale pain
Possible numbness

4 Skin blanched, translucent
Skin tight, leaking
Skin discolored, bruised, swollen
Gross edema >6 inches in any direction
Deep pitting tissue edema
Circulatory impairment
Moderale/severe pain
Infiltration of any amount of blood product, irritant, or vesicant
Timepoint [1] 338669 0
Date of insertion to date of discharge from hospital
Secondary outcome [2] 338670 0
Primary outcome
Pain on infusion - Wong-Baker FACES rating scale
Timepoint [2] 338670 0
Pain checked upon each instance of intravenous infusion
Secondary outcome [3] 338671 0
Insertion time - Measured with a stopwatch
Timepoint [3] 338671 0
Day of insertion(s)
Secondary outcome [4] 339354 0
Attempts at intravenous line insertion - Number of attempts at catheterisation/cannulation until successful insertion
Timepoint [4] 339354 0
Date of insertion to date of discharge from hospital
Secondary outcome [5] 339355 0
Duration of intravenous treatment
Timepoint [5] 339355 0
Date of insertion to date of discharge from hospital
Secondary outcome [6] 339460 0
Number of times intravenous line is replaced
Timepoint [6] 339460 0
Date of insertion to date of discharge from hospital
Secondary outcome [7] 339461 0
Cost analysis - Cost-minimisation analysis via cost of EPICs/cannulae and time-cost of insertion
Timepoint [7] 339461 0
Date of insertion to date of discharge from hospital
Secondary outcome [8] 339462 0
Parental satisfaction - Parental satisfaction questionnaire
Timepoint [8] 339462 0
After intravenous line is removed, prior to discharge from hospital

Eligibility
Key inclusion criteria
All children older than 1 year of age and deemed by their surgeon to require more than 48 hours of IV therapy post-surgery will be included.
All elective surgical procedures are applicable.
Parents/guardians willing and able to provide informed consent and accept study requirements.

Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring parenteral nutrition will be excluded.
Patients with skin disorders (e.g. allergies to multiple dressings), connective tissue and haematological disorders will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation via weighted minimisation.
Variables:
i. Gender (male, female)
ii. Age (1-5, 6-10, 11-16)
iii. Weight (8-10kg, 11-30kg, >30kg)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The proposed sample size for this trial is 36 children in each arm, with 72 children in total.
Results will be analysed accordingly after data extraction with dedicated statistical software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2018
Actual
6/03/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
14/01/2019
Date of last data collection
Anticipated
31/12/2018
Actual
21/01/2019
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9151 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 17663 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 297486 0
Hospital
Name [1] 297486 0
Monash Children's Hospital
Country [1] 297486 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Road,
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 296687 0
None
Name [1] 296687 0
Address [1] 296687 0
Country [1] 296687 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298586 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 298586 0
Ethics committee country [1] 298586 0
Australia
Date submitted for ethics approval [1] 298586 0
15/11/2017
Approval date [1] 298586 0
14/12/2017
Ethics approval number [1] 298586 0
HREC/17/MonH/534

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

Contacts
Principal investigator
Name 77566 0
Mr Maurizio Pacilli, MBBS (Hons), MD (Res), FRCS (Paed. Surg.)
Address 77566 0
Department of Paediatric General Surgery
Level 5, Monash Children’s Hospital
Monash Health
246 Clayton Road, Clayton, VIC 3168
Country 77566 0
Australia
Phone 77566 0
+61385723837
Fax 77566 0
Email 77566 0
[email protected]
Contact person for public queries
Name 77567 0
Kirby Qin, MBBS student Monash University
Address 77567 0
Department of Paediatric General Surgery
Level 5, Monash Children’s Hospital
Monash Health
246 Clayton Road, Clayton, VIC 3168
Country 77567 0
Australia
Phone 77567 0
+61385723837
Fax 77567 0
Email 77567 0
[email protected]
Contact person for scientific queries
Name 77568 0
Maurizio Pacilli
Address 77568 0
Department of Paediatric General Surgery
Level 5, Monash Children’s Hospital
Monash Health
246 Clayton Road, Clayton, VIC 3168
Country 77568 0
Australia
Phone 77568 0
+61385723837
Fax 77568 0
Email 77568 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
In line with our ethics approval, participant data will be made anonymous and will be aggregated for the purpose of statistical analyses. Findings will be reported at the group/condition level rather than the individual participant level.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo In children receiving surgery, intraoperative inse... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStandard versus long peripheral catheters for multiday IV therapy: A randomized controlled trial.2021https://dx.doi.org/10.1542/peds.2020-000877
N.B. These documents automatically identified may not have been verified by the study sponsor.