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Trial registered on ANZCTR


Registration number
ACTRN12619001304123
Ethics application status
Approved
Date submitted
9/08/2019
Date registered
23/09/2019
Date last updated
5/11/2021
Date data sharing statement initially provided
23/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a closed loop-blood sampling system in the intensive care: a pilot randomised controlled trial.
Scientific title
Evaluation of a closed loop-blood sampling system in the intensive care: a pilot randomised controlled trial.
Secondary ID [1] 298560 0
None
Universal Trial Number (UTN)
Trial acronym
ENCLOSE
Linked study record
no linked study

Health condition
Health condition(s) or problem(s) studied:
iatrogenic anaemia 313333 0
catheter associated bloodstream infection (CABSI) 313334 0
Condition category
Condition code
Anaesthesiology 311775 311775 0 0
Anaesthetics
Blood 312616 312616 0 0
Anaemia
Infection 312617 312617 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this group will receive a closed system for blood sampling attached to their arterial catheter (AC) and infusing 0.9% Sodium Chloride to keep vessel open. All arterial blood gas samples will be sampled using 1.5mL primed syringe (Beckton Dickinson and Company). All laboratory test blood samples will be drawn from the CS by the attending ICU nurse as in normal for ICU scope of practice with the use of small volume blood collection tubes using the following procedure:

Drawing the clearing volume
• Turn the handle on the sampling site into the prime/clear position. Release plunger latch and smoothly draw back on the reservoir plunger until the plunger stops at its 12ml volume capacity. (Recommended draw rate is 1 second for each ml).
• Close the shut-off valve by turning the handle perpendicular to the tubing.
• Decontaminate the sampling port with SoluPrep™ Antiseptic wipe (3M™). Ensure plunger is depressed to the bottom of reservoir. Connect the syringe to sampling site.
• Slowly draw the blood sample.
• Remove the syringe from the sampling site.
• Open the shut-off valve by turning the handle parallel to tubing.
• Slowly, smoothly, and evenly, reinfuse the clearing volume. (Recommended infusion rate is 1 second for each ml).
• Flush the VAMP Plus system by pulling the Snap-Tab on the TruWave transducer and disinfect and remove any excess blood from the sample port with SoluPrep™ Antiseptic wipe (3M™). Afterwards, turn the handle on the sample site back to the pressure monitoring position.
• All blood samples, with the exception of arterial blood gas (ABG) tests and peripheral blood cultures, will be taken using small volume blood collection tubes. Small volume blood collection tube volumes are as follows: EDTA 2 mL, SST 3.5 mL and Citrate 1.8 ml; total 7.3 mL for full blood count, Chem20 and coagulation screen tests.
• ABGs and peripheral blood culture tests will be sampled as per the RBWH ICS standard procedure (as per usual control practice).
• Throughout the entire process, no parts of the arterial catheter system will be removed and the system is completely closed.

Nurses will be performing the collection of blood samples in both study arms in line with normal practice as a Critical Care Nurse. Following complete education and orientation to intervention system. Weekly observation of blood sampling practice will be conducted by the Research Nurse throughout the study to monitor practice and protocol fidelity.Blood collection time varies depending on number of tests ordered for e.g. collection of a single arterial blood gas (ABG) may take 2-3 mins; collection of multiple blood samples (Full Blood Count, Urea and Electrolytes, Liver function Tests or even drug assays and Blood culturing) would take longer 5-10 minutes.
Intervention code [1] 314775 0
Prevention
Comparator / control treatment
Open System (OC) sampling
Participants in this group will receive an open system (OC) for blood sampling attached to their arterial catheter (AC) and infusing 0.9% Sodium Chloride to keep vessel open. All laboratory samples will be collected from the AC using a 3-way tap system, and thus an initial volume will be discarded in the sampling process. All arterial blood gas samples will be sampled using 1.5mL primed syringe. Standard volume blood collection tubes will be used for all sample collection using the following steps according to the RBWH ICS Procedure for Intra Arterial Blood sampling:
• The nurse follows steps for aseptic non-touch technique (ANTT)® prepares and brings all equipment to bedside and washes hands. The Combi-Stopper (B. Braun™) cap of the 3-way stopcock will be removed and a sterile syringe will be inserted into the stopcock port after the port is cleaned with SoluPrep™ Antiseptic wipe (3M™).
• After three (3) mL of line clearance (infusate and blood) is obtained, the first syringe will be removed and discarded and another sterile syringe will be inserted into the stopcock port for obtaining the required amount of blood (for sampling).
• After completion of sampling the port remains open (with circuit closed to patient) and the port is flushed with 0.9% sodium chloride from the attached IVAS on to sterile gauze to remove residual blood.
• Then the port is closed (and circuit open to patient) and a new cap/NC place on port. Normal Saline in the flush device is infused into the arterial catheter system to clear the distal end of the circuit.
• Throughout the entire process, the cap is off, leaving the 3-way stopcock port open to the outside and 2 sterile syringes are needed.
Control group
Active

Outcomes
Primary outcome [1] 320460 0
The primary outcome for the pilot RCT will be feasibility of a full trial. This will be established by composite analyses of elements of feasibility including eligibility, recruitment, retention and attrition, protocol adherence, missing data, intervention acceptability and effect size estimates where;

i. Eligibility: over 80% of screened patients meeting all inclusion and no exclusion criteria;
ii. Recruitment: over 80% 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] 320460 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] 320461 0
Total blood sample loss per patient per day (blood sample and discard volumes) as measured contemporaneously in the digital chart.
Timepoint [2] 320461 0
measured daily until discharge from ICU or removal of arterial catheter, whichever is first
Secondary outcome [1] 371671 0
Haemoglobin changes
Timepoint [1] 371671 0
measure daily until discharge from ICU or removal of arterial line, whichever is first
Secondary outcome [2] 371672 0
Microbiological: Exploratory cultures and bacterial DNA testing of arterial catheter tip and intraluminal fluid, plus biofilm formation.
Timepoint [2] 371672 0
measured from arterial catheter tips within 24hours of catheter removal with concomitant collection and storage of samples
Secondary outcome [3] 371673 0
Infection (all cause, primary and/or catheter associated blood stream infection)
Timepoint [3] 371673 0
assesses daily until 48 hours post arterial catheter removal or discharge from ICU
Secondary outcome [4] 371674 0
Arterial catheter (AC) dwell time - Research staff will calculate time (in hours) from device insertion until removal using relevant information as recorded by either Research Nurse on data collection from or by clinical staff in the patient's chart and/or medical record.
Timepoint [4] 371674 0
calculated upon removal of arterial catheter upon
Secondary outcome [5] 371675 0
all cause arterial catheter (AC) failure - measured as a composite of infection (laboratory confirmed local or bloodstream infection), occlusion, dislodgement (complete or partial), infiltration / extravasation, local arterial inflammation, thrombosis, and inaccurate arterial pressure trace. This composite measure incorporates the multifocal path to the same endpoint; AC failure. These will be assessed by either the Research Nurse (during daily checks) and recorded in data collection form or identified in a review of the patient's chart and/or medical record.
Timepoint [5] 371675 0
assessed daily until discharge from ICU or arterial catheter removed, whichever is first
Secondary outcome [6] 371676 0
Administration set (AS) dwell time - measured in hours from time of initial connection until time of AS change and/or arterial catheter (AC) removal as documented in patient's medical chart
Timepoint [6] 371676 0
measured throughout trial and at removal of AC
Secondary outcome [7] 371677 0
Arterial catheter (AC) dwell time - measured from time of insertion to time of AC removal as documented in patient's electronic medical chart
Timepoint [7] 371677 0
at time of AC removal
Secondary outcome [8] 371747 0
all cause mortality
Timepoint [8] 371747 0
assessed daily throughout trial until 48 hours after discharge or removal of arterial catheter
Secondary outcome [9] 371753 0
adverse events (device failure, study related infection or death) - Noted at time of event and/or confirmed by medical chart
Timepoint [9] 371753 0
monitored daily throughout trial until 48 hours post discharge or arterial catheter removal
Secondary outcome [10] 374785 0
Blood transfusion use - recorded from daily medical record
Timepoint [10] 374785 0
measured daily throughout trial until discharge or arterial catheter removed, whichever is first

Eligibility
Key inclusion criteria
All patients aged 18 years or older in the ICU will be approached for enrolment in the study if they meet the following criteria:

• Insertion of AC in the ICU has been clinically indicated and agreed upon by the medical team.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• AC inserted under emergency condition (i.e. outside the ICU).
• Laboratory confirmed bloodstream infection (within previous 48 hours)
• Clinical concern of line infection confirmed by ICS medical staff
• Presence of coexistent AC catheter
• Consent declined or active withdrawal from study
• Previous enrolment in the 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)
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)
Computer generated randomisation in permuted blocks on a 1:1 ratio for the two study groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Blinding of outcome assessors: Blinded microbiologist and infectious diseases physicians will assign infectious outcomes. Biostatistician will be blinded to grouping.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility outcomes will be assessed using descriptive statistics. Analysis will use ‘intention to treat’ with patients the unit of measurement. Baseline group comparisons will be by clinical parameters. Changes in blood sample and line clearance/discard volumes will be analysed using parametric or non-parametric inferential statistics dependent on distribution of data. Relative incidence rates of colonisation (95% CIs) will summarise treatment impacts, with group differences tested. Kaplan-Meier survival curves (+ log rank Mantel-Cox test) will compare failure over time. Secondary endpoints of AC failure, dwell-time, costs, colonisation, breakage, staff satisfaction scores, adverse events will be compared between groups using parametric/nonparametric techniques. Cox regression will test the effect of patient and device variables associated with infection and blood loss. Data will be exported into SPSS Statistics Software (Version 25, IBM®) after cleaning outlying figures, missing and implausible data, with a random 5% sample of source data re-checked. All attempts will be made to collect the primary endpoint. Missing data will be modelled for best- and worst-case outcomes. A per-protocol analysis will assess the effect of protocol violations. P <0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2019
Actual
1/11/2019
Date of last participant enrolment
Anticipated
28/02/2020
Actual
4/07/2020
Date of last data collection
Anticipated
28/03/2020
Actual
22/07/2020
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14020 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 26810 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 303072 0
Hospital
Name [1] 303072 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 303072 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
1 Butterfield Street Herston Brisbane Qld 4029
Country
Australia
Secondary sponsor category [1] 303055 0
University
Name [1] 303055 0
Queensland University of Technology
Address [1] 303055 0
Victoria Park Road, Kelvin Grove Brisbane Qld 4059
Country [1] 303055 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303620 0
Metro North Hospital and Health Services Human Research Ethics Committee
Ethics committee address [1] 303620 0
Ethics committee country [1] 303620 0
Australia
Date submitted for ethics approval [1] 303620 0
13/05/2019
Approval date [1] 303620 0
13/06/2019
Ethics approval number [1] 303620 0
HREC/2019/QRBW/52485
Ethics committee name [2] 303634 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 303634 0
Ethics committee country [2] 303634 0
Australia
Date submitted for ethics approval [2] 303634 0
30/07/2019
Approval date [2] 303634 0
02/08/2019
Ethics approval number [2] 303634 0
1900000685

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

Contacts
Principal investigator
Name 94286 0
Prof Fiona Coyer
Address 94286 0
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Butterfield St., Herston, QLD 4029.
Country 94286 0
Australia
Phone 94286 0
+61 7 3646 2140
Fax 94286 0
Email 94286 0
f.coyer@qut.edu.au
Contact person for public queries
Name 94287 0
Fiona Coyer
Address 94287 0
Level 2, Centre for Clinical Nursing, Royal Brisbane and Women’s Hospital, Butterfield St., Herston, QLD 4029.
Country 94287 0
Australia
Phone 94287 0
+61 7 3646 2140
Fax 94287 0
Email 94287 0
f.coyer@qut.edu.au
Contact person for scientific queries
Name 94288 0
Samantha Keogh
Address 94288 0
QUT School of Nursing, Victoria Park Road, Kelvin Grove, Brisbane Qld 4059
Country 94288 0
Australia
Phone 94288 0
+61 7 3138 3881
Fax 94288 0
Email 94288 0
s2.keogh@qut.edu.au

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.