Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000089336
Ethics application status
Approved
Date submitted
10/01/2017
Date registered
17/01/2017
Date last updated
17/09/2020
Date data sharing statement initially provided
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrated versus nOn-integrated Peripheral inTravenous catheter in adult hospitalised patients. Which Is the most clinical and cost-effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM randomised controlled trial)
Scientific title
Integrated versus nOn-integrated Peripheral inTravenous catheter in adult hospitalised patients. Which Is the most clinical and cost-effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM randomised controlled trial)
Secondary ID [1] 290873 0
Nil
Universal Trial Number (UTN)
U1111-1191-4336
Trial acronym
The OPTIMUM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical and cost-effectiveness of two peripheral intravenous catheter (PIVC) systems to prevent peripheral intravenous catheter complications and failure. 301575 0
Condition category
Condition code
Public Health 301286 301286 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two-arm randomised controlled trial including 2200 adults (18yrs and older) patients. Prospective patients scheduled to have a PIVC inserted and meet the inclusion criteria will be invited to participate.

Arm 1: The BD Nexiva closed IV catheter system is an integrated PIVC system. BD Nexiva consists of a number of key components incorporated as one piece: IV catheter, stabilization platform, finger grips, needle safety shield, extension tubing, pinch clamp, Y adapter (double port catheter), and vent plug. The Nexiva catheter is available in a range of sizes from 18 up to 24 gauge and as a single or double port. In this study, the double port will be used; therefore two BD SmartSite connectors will be added to close the Y-connector completely (1100 participants).

Arm 2: The traditional non-integrated system is different to the integrated system in that all the components are separated pieces, which need to be attached during cannulation. In this study, the B Braun Introcan Safety 3 or BD Insyte Autoguard catheter will be used. Key components of this catheter are: IV catheter, needle, transparent catheter hub, push-off plate, flashback chamber, removable vented flashplug, safety mechanism (to cover the needle tip). A Connecta extension set 15cm with SmartSite connector/s will be attached to the catheter (1100 participants).

Insertion and care of the PIVCs: Study and control catheters will be inserted by trained clinicians at each hospital, who are existing skilled or competent IV inserters. Pre-trial they will have training and simulated practice inserting the study catheter until they feel confident that their skills are at the same level as the control catheter insertion. The training will be provided by a Research Fellow and a Clinical Nurse (both specialists in vascular access devices), and will consist of a single 3-hour workshop with a maximum of six participants. During the training, educative videos with content on the characteristics of the integrated system, insertion techniques, dressing, care, and removal of the device will be shown, followed by a discussion on the main differences between the non-integrated and the integrated systems as well as a Q&A section. After the theoretical content is delivered, clinicians will practice the insertion of the device on insertion arms until they feel equally confident using the integrated catheter (level of confidence >80%). We anticipate 15-20 successful insertions will be sufficient.

Patients will have a single PIVC entered into the study. As PIVCs can fail at any time of day and need to be replaced quickly, it is not possible to have subsequent insertions for that patient follow the study protocol. This is because the general hospital staff would not be trained in integrated PIVC insertion. Once patients have a failed PIVC, they will receive the standard institutional PIVC inserted by the hospital staff, and are no longer on the trial. During the trial, patients will have other aspects of PIVC care standardised in all study groups, consistent with usual practice. The devices will remain in situ as per hospital policy.
All other PIVC insertion and care practices will be as per individual site policy e.g. skin preparation, dressings, etc,
Intervention code [1] 296820 0
Treatment: Devices
Comparator / control treatment
Non-integrated system: B Braun Introcan Safety 3 or BD Insyte Autoguard catheter, Conneta extension set 15cm, with SmartSite connector/s.
Control group
Active

Outcomes
Primary outcome [1] 300699 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 [1] 300699 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] 330650 0
Failure type (occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, haematoma, localised or bloodstream catheter-related infections)
Timepoint [1] 330650 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] 330651 0
Device colonisation: From the Qld site, approximately 468 (234 per group) PIVC tips will be analysed by the semi-quantitative method in the Griffith University laboratory. PIVC tips 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] 330651 0
24-76 hours after catheter removal
Secondary outcome [3] 330652 0
Insertion pain (NRS 0=no pain, 10=extreme pain)
Timepoint [3] 330652 0
Right after catheter insertion
Secondary outcome [4] 330653 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 [4] 330653 0
Clinical assessment will be performed daily and upon catheter removal.
Secondary outcome [5] 330654 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 [5] 330654 0
During the the dwell of the catheter and up to 48 hours of catheter removal
Secondary outcome [6] 330655 0
Mortality
Timepoint [6] 330655 0
During the the dwell of the catheter and up to 48 hours of catheter removal. Revision of hospital records will be performed to determine if the cause of death was associated to the catheter.
Secondary outcome [7] 330656 0
Cost-effectiveness:
We will quantify additional costs, benefits, net monetary benefit, considering PIVCs indwelling time, reinsertions and treatment costs of complications/group. Cost-analyses using ANCOVA will be undertaken to compare group costs. P-values <0.05 will be statistically significant.
Timepoint [7] 330656 0
One month after completion of study
Secondary outcome [8] 330786 0
Learning curve for integrated IV system clinicians who are current specialist or competent inserters will be trained on using the integrated PIVC system. Number of simulated insertions, and/or clinical insertions, for clinicians to feel >80% and >90% confidence for 1st time insertion success Feedback from clinicians about the process of developing this skill using ‘think-aloud’ method with a second clinician recording field notes.
Timepoint [8] 330786 0
Pre-trial
Secondary outcome [9] 330790 0
Clinical inserter’s reported ease of inserting, accessing (e.g. giving meds/flush), securing, dressing and/or overall care (0 = not easy to 10 very easy) (N=100 - 50 at each site).
Timepoint [9] 330790 0
Six months after commencement of the study
Secondary outcome [10] 330791 0
Policy drivers and decision makers’ views on the barriers and enablers of decisions about PIVC policy, and potential implementation of integrated system PIVCs: focus group/one-on-one interviews.

Timepoint [10] 330791 0
Once the trial results are available
Secondary outcome [11] 336878 0
Health related quality of life: EuroQol five dimensions questionnaire (EQ-5D) (minimum n=200; maximum 350)
Timepoint [11] 336878 0
This instrument will be administered twice: (1) prior to the insertion of the PIVC (baseline), and (2) second daily visit (approx. 48hr +/- 12 hr) from enrollment.
Secondary outcome [12] 336879 0
Patient satisfaction survey: Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – General (FACIT-TS-G (50%) or AHPEQS (50%)) (minimum n=200; maximum 350)
Timepoint [12] 336879 0
Second daily visit (approx. 48hr +/- 12 hr) from enrollment.

Eligibility
Key inclusion criteria
>18 years
PIVC to be inserted for clinical care for predicted >24 hours
Patient has given informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
PIVC placed under emergency conditions with inappropriate aseptic technique
Current bloodstream infection (positive blood culture within 48 hours)
Coexistent catheter (PIVC, intravenous midline, peripherally inserted central catheter or central venous catheter)
Language or cognitive barrier to consent
Previous enrolment in this study

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)
Central web-based service (Griffith University) with randomly varied block sizes
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be cleaned and checked for missing and invalid values before importing into STATA. Descriptive characteristics and survey results will be presented using means and standard deviations (SDs) or medians and interquartile ranges (IQRs) for continuous variables and percentages for categorical variables. All randomised patients will be analysed by intention to treat with patients the unit of measurement and one PIVC per patient. Chi-squared or Fisher’s exact tests will be used to compare qualitative variables and the Student’s t test to compare quantitative variables. The primary analysis will compare the integrated and non-integrated groups. Baseline group comparisons will be by clinical parameters. Kaplan-Meier survival curves will be used to display the rate of events in relation to catheter-hours and catheter-days, with the log rank test used to compare differences in failure over time. Secondary endpoints will be compared between groups using parametric/nonparametric techniques. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure, and assess for an interaction effect. A per-protocol analysis will assess the effect of protocol violations. We will quantify additional costs, benefits, net monetary benefit, considering PIVCs indwelling time, reinsertions and treatment costs of complications/group. Cost-analyses using ANCOVA will be undertaken to compare group costs. P-values <0.05 will be statistically significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
24/07/2017
Actual
19/07/2017
Date of last participant enrolment
Anticipated
30/11/2019
Actual
17/12/2019
Date of last data collection
Anticipated
2/12/2019
Actual
21/12/2019
Sample size
Target
2200
Accrual to date
Final
1759
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7243 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 8535 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [3] 13567 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 15010 0
4029 - Herston
Recruitment postcode(s) [2] 16629 0
4108 - Coopers Plains
Recruitment postcode(s) [3] 26213 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 295304 0
Commercial sector/Industry
Name [1] 295304 0
Becton, Dickinson and Company
Country [1] 295304 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Rd, Nathan QLD 4111, Brisbane, Australia.
Country
Australia
Secondary sponsor category [1] 294128 0
None
Name [1] 294128 0
Address [1] 294128 0
Country [1] 294128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296639 0
GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 296639 0
Ethics committee country [1] 296639 0
Australia
Date submitted for ethics approval [1] 296639 0
23/12/2016
Approval date [1] 296639 0
05/01/2017
Ethics approval number [1] 296639 0
2017/002
Ethics committee name [2] 296640 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [2] 296640 0
Ethics committee country [2] 296640 0
Australia
Date submitted for ethics approval [2] 296640 0
04/11/2016
Approval date [2] 296640 0
20/12/2016
Ethics approval number [2] 296640 0
HREC/16/QRBW/527
Ethics committee name [3] 296642 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [3] 296642 0
Ethics committee country [3] 296642 0
Australia
Date submitted for ethics approval [3] 296642 0
08/11/2016
Approval date [3] 296642 0
06/12/2016
Ethics approval number [3] 296642 0
Approved

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

Contacts
Principal investigator
Name 71602 0
Prof Claire Rickard
Address 71602 0
N48, room 2.12 Griffith University 170 Kessels Rd, Nathan QLD 4111
Country 71602 0
Australia
Phone 71602 0
+ 61 (07) 373 56460
Fax 71602 0
Email 71602 0
[email protected]
Contact person for public queries
Name 71603 0
Claire Rickard
Address 71603 0
N48, room 2.12 Griffith University 170 Kessels Rd, Nathan QLD 4111
Country 71603 0
Australia
Phone 71603 0
+61 (07) 373 56460
Fax 71603 0
Email 71603 0
[email protected]
Contact person for scientific queries
Name 71604 0
Claire Rickard
Address 71604 0
N48, room 2.12 Griffith University 170 Kessels Rd, Nathan QLD 4111
Country 71604 0
Australia
Phone 71604 0
+61 (07) 373 56460
Fax 71604 0
Email 71604 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
The current conditions set by the approving Human Research Ethics Committee/s do not provide approval for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
826Study protocol    https://bmjopen.bmj.com/content/8/5/e019916.info 372136-(Uploaded-18-12-2018-11-14-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIntegrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): A randomised controlled trial protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-019916
EmbaseHealth-related quality of life and experience measures, to assess patients' experiences of peripheral intravenous catheters: a secondary data analysis.2024https://dx.doi.org/10.1186/s12955-023-02217-8
N.B. These documents automatically identified may not have been verified by the study sponsor.