Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001642279
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
4/10/2018
Date last updated
3/12/2020
Date data sharing statement initially provided
11/01/2019
Date results information initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
CHest optimisation through antibiotics Infused via Midline or Peripherally inserted central catheter trial: A randomised controlled trial
Scientific title
A randomised controlled trial comparing the cost and clinical effectiveness of midline to PICC for delivering intravenous antibiotics to children requiring intensive pulmonary optimisation.
Secondary ID [1] 295923 0
Nil
Universal Trial Number (UTN)
Trial acronym
The CHIMP trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis (CF) 309412 0
non-CF bronchiectasis 309722 0
bronchiolitis 309723 0
Condition category
Condition code
Public Health 308269 308269 0 0
Health service research
Respiratory 308270 308270 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 308526 308526 0 0
Cystic fibrosis
Infection 308589 308589 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 3fr, 4fr (outer lumen midline size); power injectable midline catheter. Catheter size chosen by the operator inserting the device.
A midline catheter begins its insertion in a peripheral vein in the upper arm. Midlines are shorter devices and the tip of the midline terminates at the axilla. Xray is not required to check catheter tip position.

All catheters will be inserted by and appropriately trained anaesthetic consultant, registrar, fellow or nurse practitioner in vascular access. All care and maintenance will be performed by appropriately trained nurses in the clinical area.
All catheters will remain in place for the period of treatment between 12-21 days.
Where a device is complicated by failure and a replacement device is required the same device will be reinserted if the patient and substitute decision maker are agreeable.
Intervention code [1] 312245 0
Treatment: Devices
Comparator / control treatment
Arm 1 - (Control): 3fr, 4fr (outer lumen size) Peripherally Inserted Central Catheter (PICC). PICCs begin their insertion at a peripheral vein in the upper limb and are advanced into a more central position, i.e. cavo-atrial junction. X-ray is usually required to ensure the tip of the catheter is in the right position.
Control group
Active

Outcomes
Primary outcome [1] 307231 0
Feasibility :
Feasibility of a full-scale efficacy trial will be established by a demonstration that:
• Greater than 75% of patients screened are eligible and,
• Greater than 80% of eligible participants agree to enrol and,
• Greater than 80% of participants in the intervention groups receive their allocated treatment and,
• Less than 5% of participants are lost to follow up and,
• There is less than 5% missing data and,
• Parents and healthcare staff report > 80% satisfaction and acceptability with the study intervention.
Timepoint [1] 307231 0
At completion of trial
Primary outcome [2] 307232 0
General Anaesthetic during pulmonary optimisation:
General Anaesthetic will be established by the Vascular Access Device insertion necessitating a General Anaesthesia that would not otherwise be required. This outcome will be assessed at time of device insertion during data collection and also available in the electronic medical record.
Timepoint [2] 307232 0
At removal of device.
Secondary outcome [1] 351196 0
Delays to initiation of treatment: Time between decision made to administer treatment and treatment commenced.
This information will be collected through data-linkage to medical record, time decision to insert device documented to time of first medication delivery.
Timepoint [1] 351196 0
Following device insertion.
Secondary outcome [2] 351197 0
Time to insert: Time from the start of the PICC or ML placement until radiographic confirmation of tip position and device ready for use.
This information is collected by stopwatch to provide accurate time of the procedure.
Timepoint [2] 351197 0
Following device insertion.
Secondary outcome [3] 351198 0
Delays throughout treatment: Any delay that occurs from the time the antibiotic was due to be administered to the time the antibiotic was actually administered as a result of device failure or malfunction.
Timepoint [3] 351198 0
At completion of trial participation
Secondary outcome [4] 351199 0
Cost analysis: Estimates of direct product costs, healthcare resource utilisation (including additional equipment, staff time) and failure-associated resource usage using previously established cost estimates (Qhealth FAMMIS).
A study-specific questionnaire will be established to collect all products used.
Timepoint [4] 351199 0
At study completion
Secondary outcome [5] 351200 0
Device failure: Cessation of device function due to any complication (CABSI, thrombosis, occlusion, fracture, infiltration, dislodgement, too painful to tolerate) prior to completion of therapy, assessed by linkage to medical records and during daily data collection by research nurse.
Timepoint [5] 351200 0
At completion of trial participation.
Secondary outcome [6] 351201 0
Child’s procedural pain using 11-point scales (0=no pain, 10=worst pain)
Timepoint [6] 351201 0
Within 24 hours of device insertion
Secondary outcome [7] 351202 0
Clinician experience: ease of insertion using a 11-point scale (0=very difficult, 10=very easy)
Timepoint [7] 351202 0
Within 24 hours of device insertion
Secondary outcome [8] 351203 0
Patient and/or parent experience: Qualitative acceptability
using 11-point scales (0=unacceptable, 10=acceaptable)
Timepoint [8] 351203 0
Following device removal
Secondary outcome [9] 351204 0
Efficiency of device to deliver therapeutic dose via infusor in 24 hour period. Determined by weight of infusor at beginning of 24 hour period, compared to weight of infusor at the end of 24 hour period. Efficiency of delivery will be determined by greater than 80% of device delivered during 24 hour period.
Timepoint [9] 351204 0
Twice weekly
Secondary outcome [10] 351205 0
Additional VAD’s: Any additional VAD that is required to complete or supplement therapy due to delays to initiation of treatment or provide interim access to resolve complication of device. Data will be collected from electronic medical record and during twice weekly review by research nurse.
Timepoint [10] 351205 0
Following device removal.
Secondary outcome [11] 352088 0
Parent's procedural anxiety using 11-point scales (0=no anxiety, 10=worst anxiety).
Timepoint [11] 352088 0
within 24 hours of device insertion

Eligibility
Key inclusion criteria
. Respiratory diagnosis of CF or any other respiratory diagnosis including, non-CF bronchiectasis
• 0 (>37 weeks) – 18 years of age (17 years + 364 days)
• Referred to the vascular assessment and management service (VAMS) for insertion of a vascular access device to facilitate antibiotic therapy for pulmonary optimisation.
• Infusates deemed compatible with peripheral/midline administration based on assessment of venous infusion extravasation risk
English speaking
Able to provide consent
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria



Update
• Non-english speaking parent
• Unable to provide consent
• Previous enrolment in current trial
• Thrombosis at level of axillar or sub-clavian that precludes insertion of midline or PICC
- Medical diagnosis of behavioural condition. e.g. autism, ADHD that would make it impossible for a child to co-operate to a level necessary to have the device inserted with anaesthesia.

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)
A web-based central randomisation service to obtain group allocation will be used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation with a 1:1 ratio between the two groups with randomly varied block sizes
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
All randomised patients will be analysed by intention to treat, irrespective of treatment. The patient is the unit of measurement with one device per patient being analysed. For this pilot trial, we will test the feasibility of the trial by using the criteria defined for the Primary outcome. Logistic regression will be used to compare percentage of patients requiring a general anaesthesia for insertion of midline, in comparison to peripherally inserted central catheters (PICC)s, for children requiring pulmonary optimisation. Univariable analysis will include group, baseline patient and device characteristics, and potential confounders. Rates of anxiety and difficulty will be compared between the groups using Independent samples t-tests.
Qualitative data will be thematically analysed using the procedures outlined by Braun and Clarke. Qualitative analysis will be conducted using Grounded Theory. Comparative cost-analysis will be assessed by health economist considering; purchase price, staff time, operating room costs, inpatient bed days and costs of treating complications or re-insertion of device if necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2019
Actual
29/01/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
17/03/2020
Date of last data collection
Anticipated
12/01/2020
Actual
8/07/2020
Sample size
Target
110
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11744 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 23826 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 300522 0
Charities/Societies/Foundations
Name [1] 300522 0
The Children’s Hospital Foundation
Country [1] 300522 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 299997 0
None
Name [1] 299997 0
Address [1] 299997 0
Country [1] 299997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301311 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Commitee
Ethics committee address [1] 301311 0
Level 7, Centre for Children's Health Research Queensland Children's Hospital Precinct 62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 301311 0
Australia
Date submitted for ethics approval [1] 301311 0
16/07/2018
Approval date [1] 301311 0
26/07/2018
Ethics approval number [1] 301311 0
HREC/18/QRCH/160

Summary
Brief summary
Children with respiratory illness including CF and non CF bronchiectasis are the largest cohort of children requiring PICCs at Queensland Children's Hospital (QCH). Traditionally PICCs require a general anaesthesia to establish procedural compliance. Midlines are also used internationally to administer intravenous antibiotics without necessitating general anaesthesia. We hypothesise that the need for GA will be reduced in this patient cohort whilst still providing the necessary treatment. This will benefit this patient population and the healthcare institution through reduced procedural risk and corresponding respiratory compromise, as well as reduced costs associated with theatre personnel. . The primary aims of this research is 1) to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity and 2) need for general anaesthetic.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86590 0
Ms Tricia Kleidon
Address 86590 0
Department of Anaesthesia and Pain Management Level 7f, Queensland Children’s Hospital, Queensland 501 Stanley St, South Brisbane, Qld 410
Country 86590 0
Australia
Phone 86590 0
+61 7 3068 1135
Fax 86590 0
Email 86590 0
[email protected]
Contact person for public queries
Name 86591 0
Ms Tricia Kleidon
Address 86591 0
Department of Anaesthesia and Pain Management Level 7f, Queensland Children’s Hospital, Queensland 501 Stanley St, South Brisbane, Qld 4101
Country 86591 0
Australia
Phone 86591 0
+61 7 3068 1135
Fax 86591 0
Email 86591 0
[email protected]
Contact person for scientific queries
Name 86592 0
Dr Amanda Ullman
Address 86592 0
Menzies Health Institute Queensland
Griffith University
Health Sciences (N48) Room 2.20
Nathan
QLD 4111
Country 86592 0
Australia
Phone 86592 0
+61 7 373 56462
Fax 86592 0
Email 86592 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
As per HREC requirements.


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.