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HINTS AND TIPS
DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12617000619347
Ethics application status
Approved
Date submitted
20/04/2017
Date registered
1/05/2017
Date last updated
5/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Accuracy of electrocardiogram to insert peripherally inserted central catheters (PICCs) in adult hospitalised patients
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Scientific title
Accuracy of the Delta electrocardiogram (ECG) system to verify correct peripherally inserted central catheter (PICC) tip location in adult hospitalised patients
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Secondary ID [1]
291591
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
PICC insertion
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Condition category
Condition code
Public Health
287393
287393
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. It is considered best practice for the PICC tip to terminate in a large vein near the entrance to the heart (lower third superior vena cava (SVC) or right atrium junction). Commonly, the carina (tracheal bifurcation) is used as a surrogate landmark for the commencement of the lower section of the SVC.
Currently, fluoroscopy or live x-ray is used to determine PICC tip location in many hospitals, but this is costly and requires patients to travel to the Radiology department. Many hospitals in Australia and overseas use an electrocardiogram (ECG) tip verification system for PICC insertion. The ECG tracing changes as the PICC tip approaches the right atrium junction. There is limited evidence that this system is accurate compared to fluoroscopy and the cost implications are unknown.
This research aims to compare the accuracy of an ECG tip verification system (Nautilus Delta) with fluoroscopy and determine the economic implications of a change in practice.
Patients booked for PICC insertion, as part of their usual care will be invited to participate. Patients will be excluded if they are unable to provide informed consent, have cardiac arrhythmia disorders, abnormal P-wave (atrial fibrillation) on baseline ECG and who are pregnant.
Patients will have a PICC inserted as per usual practice by the PICC inserter, an advanced practice Registered Nurse. The approximate duration of the procedure is 30 minutes. Once the tip is near the right atrium junction the PICC inserter will use the ECG trace to determine correct tip termination. Once the Nautilus Delta ECG system indicates correct PICC tip placement, fluoroscopic imaging will be performed to determine whether the tip position is in the lower third SVC or SVC/RA junction. The fluoroscopic image will be saved on the Picture Archiving and Communications System (PACS) as per usual practice. If the PICC tip location is deemed to be incorrect by the PICC inserter using fluoroscopy, the first image will be labelled as clinical trial and the PICC tip position will be adjusted. A second fluoroscopic image will be stored on PACS which will be labelled corrected tip position. An independent Medical Registrar will use inbuilt callipers to measure the distance of the PICC tip from the carina on the image stored on PACS after trial completion (solitary image or image labelled clinical trial where appropriate).
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Intervention code [1]
285400
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Treatment: Devices
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Comparator / control treatment
Fluoroscopy will be sued as the comparatorfor all groups
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Control group
Active
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Outcomes
Primary outcome [1]
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The accuracy of the Nautilus Delta ECG tip confirmation system to indicate PICC tip placement within the lower third SVC or lower third SVC/right atrium junction as confirmed by fluoroscopy.
This is defined as a PICC tip that terminates within 50mm distal to the carina.
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Assessment method [1]
287661
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Timepoint [1]
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PICC tip will be confirmed at time of PICC placement using fluoroscopy.
Measurement of carina to PICC tip will be performed at trial conclusion
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Secondary outcome [1]
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Economic cost of using fluoroscopy and the Nautilus Delta system to verify tip location.
Information for the economic analysis, including cost of consumables and fluoroscopy as well as staff allocation will be obtained from the hospital and distributor of the Nautilus Delta system. West Australian enterprise agreements will be accessed to determine wage costs.
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Assessment method [1]
333354
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Timepoint [1]
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Trail conclusion
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Eligibility
Key inclusion criteria
All adult (18 years or older) patients booked for a single, double or triple lumen PICC insertion above the ante-cubital fossa region (usual practice) by the PICC nurse inserter in the Radiology Department.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inability to provide informed consent due to neurological or language barriers (diagnosis of dementia; uncontrolled mental illness or deficits; inability to read, write or understand English).
Participants with known cardiac arrhythmia disorders (Atrial Fibrillation, Atrial Flutter, Tachycardia) or those with Pacemakers.
Undetectable or abnormal P-wave on baseline ECG
Inability to lie flat on procedure bench
Participants who are pregnant
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
Power analysis - an exact binomial test with a nominal 0.05 one-sided significance level will have 91% power to detect the difference between 100% accuracy by the Delta system, compared to 98% accuracy by fluoroscopy when the sample size is 120.
A one sample Z test will compare the proportion of tips correctly placed using Delta to 1.0, the expected proportion correct using fluoroscopy. All results with p < 0.05 will be considered statistically significant.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
5/06/2017
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Actual
5/03/2018
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Date of last participant enrolment
Anticipated
21/10/2019
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Actual
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Date of last data collection
Anticipated
21/10/2019
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Actual
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Sample size
Target
120
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Accrual to date
20
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
15690
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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FloMedical
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Address [1]
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33 Haig St,
Netherby SA 5062
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Country [1]
296079
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Australia
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Primary sponsor type
Hospital
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Name
Fiona Stanley Hospital
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Address
11 Robin Warren Drive, Murdoch WA 6150
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of South Australia
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Address [1]
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School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Australia
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Country [1]
294975
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297338
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South Metropolitan Health Service, Human Research Ethics Committee
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Ethics committee address [1]
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11 Robin Warren Drive, Murdoch WA 6150
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Ethics committee country [1]
297338
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Australia
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Date submitted for ethics approval [1]
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06/12/2016
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Approval date [1]
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14/03/2017
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Ethics approval number [1]
297338
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REG: 2016-254
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Summary
Brief summary
Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. The ends of these tubes need to sit near the heart to reduce side effects. Commonly live xray (fluoroscopy) is used to make sure the PICC is at the right place. But this is expensive and difficult to coordinate.
ECG tracing represents different parts of the heart working and when the PICC is placed near the heart, this tracing will change. Thus, we can see when the end of the PICC is in the correct place. But, there is limited evidence that this system is accurate compared to fluoroscopy and the cost implications are unknown.
This research aims to compare the accuracy of an ECG tip verification system (Nautilus Delta) with fluoroscopy and determine the economic implications of a change in practice.
Patients already undergoing PICC insertion will be recruited at Fiona Stanley Hospital. The PICC will be inserted the usual way and when the Nautilus Delta ECG system indicates it’s in the correct area, fluoroscopy will be used to verify where the tip is. Hospital and enterprise bargaining information will be used to determine the costs associated with the different systems.
Hypothesis: the Nautilus Delta ECG system will be accurate when compared to fluoroscopy and more cost effective
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Rebecca Sharp
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Address
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School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Australia
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Country
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Australia
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Phone
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+61 8 8302 2663
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Peter Carr
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Address
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Fiona Stanley Hospital
11 Robin Warren Drive, Murdoch WA 6150
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Country
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Australia
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Phone
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:+618615 21608
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Rebecca Sharp
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Address
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School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Australia
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Country
8702
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Australia
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Phone
8702
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+61 8 8302 2663
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Fax
8702
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Email
8702
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[email protected]
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No information has been provided regarding IPD availability
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.
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