Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001780145
Ethics application status
Approved
Date submitted
29/11/2019
Date registered
16/12/2019
Date last updated
23/10/2020
Date data sharing statement initially provided
16/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Standard versUs peRForated peripheral intravenous catheter. The SURF trial: a pilot randomised controlled trial
Scientific title
Standard versUs peRForated peripheral intravenous catheter. The SURF trial: a pilot randomised controlled trial
Secondary ID [1] 299899 0
Funding body ref MNHHS CRG191
Universal Trial Number (UTN)
Trial acronym
SURF
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
vascular access failure (due to occlusion, infiltration, phlebitis, dislodgement) 315319 0
IV extravasation 315320 0
Condition category
Condition code
Anaesthesiology 313622 313622 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other than the study intervention, (type of peripheral intravenous catheter (PIVC) inserted), all other aspects of PIVC management will be as per local clinical guidelines (Royal Brisbane and Women’s Hospital, 000259: Peripheral Intravenous Cannulation and Infusion Management – Adult and Paediatrics). Hand hygiene is required prior to and throughout the insertion procedure. Skin will be prepped and decontaminated using a large swab or swab stick containing 2% Chlorhexidine Gluconate with 70% isopropyl alcohol. The antiseptic must be allowed to dry prior to inserting the IV catheter. Palpation of the insertion site should not be performed after the application of antiseptic, unless aseptic technique is maintained. If the health professional needs to re-establish the identification of the vein, the site should be re-prepped with the antiseptic solution and allowed to thoroughly dry. It is more efficient to assess the patient’s veins at the outset, determine degree of difficulty of insertion and then risk assess to ascertain if it may be more effective to wear sterile gloves to enable palpating of the cleansed area thereby maintaining Aseptic Non-Touch Technique (ANTT®). Site selection will be determined by inserter following assessment of the patient’s vessel health and in consultation with radiographer/radiologist about procedure and infusion protocol.

Study and control PIVCs will be inserted by trained clinicians (either clinical staff or research nurses), who are existing skilled or competent intravenous inserters. Pre-trial they will have training and simulated practice inserting the study PIVC, until they feel confident that their skills match their competence for control PIVC insertion. If ultrasound is used to guide insertion, this will be recorded. Weekly checks by Research Nurse (ReN) for protocol fidelity will be conducted.

A sterile transparent, semi-permeable, self-adhesive IV dressing must be placed over the insertion site (as per manufacturer recommendations). The PIVC is removed when prescribed therapy is complete or as clinically indicated.

Participants allocated to the Intervention group will have a 20g or 22g (as per clinician preference and assessment), 31.75mm BD NexivaTM DiffusicsTM catheter inserted and used for infusion of contrast. This device has both side and end hole exit points at the distal tip, as opposed a single end hole exit point in standard (control) catheter. Pre-packs of allocated products will be kept in storeroom and monitored daily by the research nurse, who will also confirm time and reason for replacements with nursing staff.
Intervention code [1] 316169 0
Prevention
Intervention code [2] 316343 0
Treatment: Devices
Comparator / control treatment
Patients in the standard care group will receive a 20g 30mm or 22g 25mm BD InsyteTM Autoguard BCTM , the gauge will be as per the inserters preference (as per patient assessment). This device has a single end hole exit point at the distal tip.
Control group
Active

Outcomes
Primary outcome [1] 322066 0
The primary outcome Study feasibility: The feasibility outcome will be determined based on the following criteria:
i. Eligibility: over 90% of screened patients meeting all inclusion and no exclusion criteria;
ii. Recruitment: over 90% of eligible patients providing informed consent (or not opting out);
iii. Retention: fewer than 5% of recruited patients lost to follow up or withdrawing consent;
iv. Protocol fidelity: over 90% of randomised patients receiving their allocated intervention;
v. Missing data: less than 5% of primary endpoint data unable to be collected by study staff; and
vi. Patient and staff acceptability with the study intervention and control: 70% of patient/parents and staff scoring greater than or equal to 7 on a 0-10 point rating scale at study completion.
Timepoint [1] 322066 0
Feasibility outcomes calculated from trial screening logs and database. Protocol fidelity determined from weekly (observational) practice audit and verbal reports by staff. Staff will be invited for to give feedback at the end of the trial.
Primary outcome [2] 322067 0
The primary outcome is PIVC failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter-related infections. a) Occlusion is defined as the inability to infuse or inject solution into a catheter. b) Infiltration/extravasation infiltration is defined as the inadvertent permeation of IV fluid (non-vesicant solution) into the interstitial compartment, causing swelling of the tissue around the site of the catheter. Extravasation is the inadvertent administration of a vesicant solution into surrounding tissue. c) Phlebitis/thrombophlebitis phlebitis is defined as irritation and inflammation of a vein wall caused by the presence of the PIVC. It is characterised by the presence of any combination of tenderness, pain, erythema, swelling, warmth, palpable cord, or purulent drainage. In this study phlebitis includes pain (>1 out of 10) alone or plus any of the criteria mentioned above (on questioning, then palpation by the research nurse). Thrombophlebitis is also characterised by a visible clot on removal and/or palpable thrombosis of the cannulated vein. All these are consequence of the inflammation of the vein wall that leads to thrombus formation. In this study the presence of thrombophlebitis will be confirmed by ultrasound of the compromised vessel (if ordered by clinicians). d) Dislodgement is defined as movement of the catheter in and out of, or around and within, the vein resulting in partial or complete dislodgement. This may be characterized as Leaking (partial dislodgement). e) Haematoma is defined as solid swelling of clotted blood within the tissue, caused by a break in the wall of the blood vessel due to the insertion of a PIVC, resulting in device malfunction and triggering the removal of the catheter.' f) Localised venous infection is defined as organisms grown from purulent discharge or vein segment with no evidence of associated bloodstream infection. g) Bloodstream infection is defined as positive blood culture from a peripheral vein; clinical signs of infection (i.e. fever, chills, or hypotension); no other apparent source for the bloodstream infection except the intravenous catheter (in situ within 48 h of the bloodstream infection); and either a colonised intravenous catheter tip culture with the same organism as identified in the blood or purulent drainage from the involved vascular site.
Timepoint [2] 322067 0
Clinical assessment will be performed daily and upon catheter removal. A review of pathology results will be performed 48 hours after catheter removal.
Secondary outcome [1] 377196 0
Failure type (occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter-related infections)
Timepoint [1] 377196 0
Clinical assessment will be performed daily and upon catheter removal. A review of pathology results will be performed 48 hours after catheter removal.
Secondary outcome [2] 377197 0
Device colonisation: Approximately 20 PIVCs (10 from each group) will be analysed by the semi-quantitative method in the QUT QIMR laboratory. PIVCs will be selected based on availability of the Research Nurse when the PIVC is removed and when transfer to the lab is available. Colonisation of intravenous catheter tip will be considered if more than 15 colony-forming units are present. Blood cultures from a peripheral vein, and PIVC skin swabs (if ordered by clinicians) will be cultured by Microbiology Pathology Queensland-Central Lab by blinded scientists
Timepoint [2] 377197 0
24-76 hours after catheter removal
Secondary outcome [3] 377198 0
number of PIVC insertion attempts by clinician inserting device measured as a continuous variable i.e. count of how many attempts were needed before successful placement of PIVC cannula achieved
Timepoint [3] 377198 0
measured at time of insertion or gathered retrospectively from medical record
Secondary outcome [4] 377199 0
first insertion success as a dichotomous variable (Yes/No)
Timepoint [4] 377199 0
measured at time of insertion
Secondary outcome [5] 377201 0
Insertion pain (NRS 0=no pain, 10=extreme pain)
Timepoint [5] 377201 0
Right after catheter insertion
Secondary outcome [6] 377202 0
Dwell time without complications. The Research Nurse will visit the participants once a day and perform a clinical assessment of the IV catheter, and record the information using ReDCap (Vanderbilt) software on hand-held devices.
For participants whose IV catheter was removed overnight, review of the hospital records will be performed.
Timepoint [6] 377202 0
Clinical assessment will be performed daily and upon catheter removal.
Secondary outcome [7] 377207 0
Acceptable Image Quality. Study images will be assessed by a Radiologist to determine whether the image is of acceptable quality. Subjective image quality assessment for acceptability will be determined by:

The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable.
Timepoint [7] 377207 0
measured at time of reporting on images
Secondary outcome [8] 377210 0
Adverse events such as infection or death. Clinical assessment will be performed daily and 48 hours after catheter removal. In addition, review of hospital records will be perform in case of death to determine if it was associated with the IV catheter.
Timepoint [8] 377210 0
During the the dwell of the catheter and up to 48 hours of catheter removal

Eligibility
Key inclusion criteria
greater than or equal to 18 years of age
PIVC required for injection of contrast as part of Cancer Care diagnosis, prognosis, and/or treatment (outpatient or inpatient)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PIVC inserted under emergency condition
Laboratory confirmed bloodstream infection (within previous 48 hours)
Non-English Speaking Background (NESB) without interpreter
Patient receiving end of life care
Cognitive barrier to consent
Previous enrolment in the study
• Known difficult intravenous access/ultra sound guided placement regularly required

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)
A participant will be considered enrolled into the study if the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents. A separate master log will be created to link the participant’s study number to their medical record. Randomisation will be via a centralised web-based service, which will ensure allocation concealment until study entry. Randomisation will be in a 1:1 ratio between the two groups with randomly varied block sizes. Study products will be in pre-packs and ReNs will liaise closely with clinicians.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility outcomes will be reported descriptively. All randomised patients will be analysed on an Intention to Treat (ITT) basis. Patients will have one PIVC entered in the study so that the unit of analysis (the patient) is independent. For this pilot trial, we will test the feasibility of the statistical analysis that will be used in the definitive trial. Prior to analysis data will be cleaned and checked. All attempts will be made to collect the primary endpoint (PIVC failure (Yes/No). Comparability of groups at baseline will be assessed using clinically relevant indicators and compared statistically using chi-squared tests to compare differences in categorical variables and independent samples t-tests to compare differences in continuous variables. Frequency and Incidence Rate Ratio (with 95% confidence intervals) of device failure will summarise the impact of the intervention. Secondary endpoints will be compared between groups for clinically significant differences, with the impact of the intervention on dwell times assessed using hazard ratio (with 95% confidence intervals) estimated from a Cox proportional hazards model and the impact of the intervention on categorical variables assessed by frequency and incidence rate ratios (with 95% confidence intervals). P values of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2020
Actual
3/03/2020
Date of last participant enrolment
Anticipated
28/02/2020
Actual
27/05/2020
Date of last data collection
Anticipated
6/03/2020
Actual
29/05/2020
Sample size
Target
60
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15305 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 28613 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 304364 0
Hospital
Name [1] 304364 0
Metro North Hospitals and Health Service collaborative research grant
Country [1] 304364 0
Australia
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Service
Address
7 Butterfield Street, Herston, Brisbane Qld 4029
Country
Australia
Secondary sponsor category [1] 304614 0
University
Name [1] 304614 0
Queensland University of Technology
Address [1] 304614 0
Victoria Park Road, Herston, Brisbane QLD 4059
Country [1] 304614 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304805 0
Metro North Hospital and Health Services Human Research Ethics Committee
Ethics committee address [1] 304805 0
Ethics committee country [1] 304805 0
Australia
Date submitted for ethics approval [1] 304805 0
29/07/2019
Approval date [1] 304805 0
28/10/2019
Ethics approval number [1] 304805 0
HREC/2019/QRBW/55616
Ethics committee name [2] 304819 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 304819 0
Ethics committee country [2] 304819 0
Australia
Date submitted for ethics approval [2] 304819 0
26/11/2019
Approval date [2] 304819 0
29/11/2019
Ethics approval number [2] 304819 0
QUTHREC/1900001090

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

Contacts
Principal investigator
Name 98270 0
Dr Nicole Gavin
Address 98270 0
Nursing and Midwifery Research Centre,
Level 2 Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
1 Butterfield Street, Herston
Brisbane QLd 4029
Country 98270 0
Australia
Phone 98270 0
+61 7 3646 5833
Fax 98270 0
Email 98270 0
[email protected]
Contact person for public queries
Name 98271 0
Nicole Gavin
Address 98271 0
Nursing and Midwifery Research Centre,
Level 2 Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
1 Butterfield Street, Herston
Brisbane QLd 4029
Country 98271 0
Australia
Phone 98271 0
+61 7 3646 5833
Fax 98271 0
Email 98271 0
[email protected]
Contact person for scientific queries
Name 98272 0
Samantha Keogh
Address 98272 0
QUT School of Nursing, Victoria Park Road, Kelvin Grove, Brisbane Qld 4059
Country 98272 0
Australia
Phone 98272 0
+61 7 3138 3881
Fax 98272 0
Email 98272 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


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.