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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
Scientific title
Accuracy of the Delta electrocardiogram (ECG) system to verify correct peripherally inserted central catheter (PICC) tip location in adult hospitalised patients
Secondary ID [1] 291591 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PICC insertion 302705 0
Condition category
Condition code
Public Health 287393 287393 0 0
Health service research

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 285400 0
Treatment: Devices
Comparator / control treatment
Fluoroscopy will be sued as the comparatorfor all groups
Control group
Active

Outcomes
Primary outcome [1] 287661 0
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.
Timepoint [1] 287661 0
PICC tip will be confirmed at time of PICC placement using fluoroscopy.
Measurement of carina to PICC tip will be performed at trial conclusion
Secondary outcome [1] 333354 0
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.
Timepoint [1] 333354 0
Trail conclusion

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2017
Actual
5/03/2018
Date of last participant enrolment
Anticipated
21/10/2019
Actual
Date of last data collection
Anticipated
21/10/2019
Actual
Sample size
Target
120
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7756 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 15690 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 296079 0
Commercial sector/Industry
Name [1] 296079 0
FloMedical
Country [1] 296079 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Drive, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 294975 0
University
Name [1] 294975 0
University of South Australia
Address [1] 294975 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Australia
Country [1] 294975 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297338 0
South Metropolitan Health Service, Human Research Ethics Committee
Ethics committee address [1] 297338 0
Ethics committee country [1] 297338 0
Australia
Date submitted for ethics approval [1] 297338 0
06/12/2016
Approval date [1] 297338 0
14/03/2017
Ethics approval number [1] 297338 0
REG: 2016-254

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

Contacts
Principal investigator
Name 34527 0
Dr Rebecca Sharp
Address 34527 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Australia
Country 34527 0
Australia
Phone 34527 0
+61 8 8302 2663
Fax 34527 0
Email 34527 0
[email protected]
Contact person for public queries
Name 17774 0
Peter Carr
Address 17774 0
Fiona Stanley Hospital
11 Robin Warren Drive, Murdoch WA 6150
Country 17774 0
Australia
Phone 17774 0
:+618615 21608
Fax 17774 0
Email 17774 0
[email protected]
Contact person for scientific queries
Name 8702 0
Rebecca Sharp
Address 8702 0
School of Nursing and Midwifery
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Australia
Country 8702 0
Australia
Phone 8702 0
+61 8 8302 2663
Fax 8702 0
Email 8702 0
[email protected]

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

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