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Trial registered on ANZCTR


Registration number
ACTRN12620000919910
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
17/09/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Date results provided
17/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing traditional Placement With placement using electrocArdiography for central Vascular access dEvices trial (P Wave Trial)
Scientific title
A randomised controlled trial of intracavitary electrocardiography versus traditional anthropometric guidance for central venous access device placement
Secondary ID [1] 301837 0
None
Universal Trial Number (UTN)
U1111-1255-7997
Trial acronym
P Wave Trial
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Central Venous Catheter Positioning 318320 0
Condition category
Condition code
Anaesthesiology 316333 316333 0 0
Other anaesthesiology
Emergency medicine 316334 316334 0 0
Other emergency care
Public Health 316335 316335 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a pragmatic, open-label randomised controlled trial comparing accuracy, timing and cost between anthropometric and intracavitary electrocardiography (IC ECG) guided CVAD insertion.

Recruitment commenced 13th of December 2016 and completed 4th July 2018 with all patient follow completed by 10th September 2018. Ethical approval to commence this study was given by the South Western Sydney Local Health District Human Research Ethics Committee (HREC/15/LPOOL/552).

CVAD insertion was performed by accredited nurses in both groups as a once off procedure (approximately 12 minutes). Maximal sterile technique with the use of ultrasound was used to gain venous access and to scan vessels during the procedure for suspected malposition.

In the intervention group a portable, wireless IC-ECG navigation system (Nautilus Delta Tip Confirmation System– BARD Access Systems, Salt Lake City USA) was used to monitor changing R wave progression as well as increasing amplitude of the P wave to confirm position. When maximum P wave amplitude was achieved, the catheter tip was deemed to be located at the cavo-atrial junction (CAJ) or upper RA and the CVAD was then secured and dressed. This particular IC-ECG read out device was already established and has been used across hospitals in Europe. Training for users was provided by a local distributor and incorporated a blended learning approach with web based material and practical demonstration. Safety monitoring for this study was undertaken using local organisational governance procedures (documenting, escalating and reviewing any procedural or latent complications).

Due to the low risk nature of the trial, no stopping rules were implemented as part of the study protocol.

In both groups, a chest x ray (CXR) was administered post catheter insertion to confirm final catheter tip position. A single radiologist, (blinded to study group) with extensive experience in CXR film interpretation, reviewed all CXRs to confirm catheter tip position using digital calipers and the tracheal carina as a measuring landmark on the computerised film. Care and maintenance of devices in both groups was based on current hospital guidelines and was not distinguished.

An independent observer documented the procedural time start time (first needle puncture of skin) and conclusion time (the sterile dressing was applied). Procedure room set up and clean up time was not included in timings. Although post procedure CXRs were performed in both groups, total procedure time was measured in the IC ECG group when sterile dressing was applied to skin, since this is when the catheter would normally be released for use after ECG confirmation. If catheters required repositioning after CXR in either group, time was measured for this additional procedure and added to the total procedure time.
Intervention code [1] 318133 0
Treatment: Devices
Comparator / control treatment
For patients randomised to control group, central line insertion was based on traditional anthropometric guided insertion (term used for externally measuring catheter insertion based on body habitus, most popular t technique used is measurement from proposed insertion site to sternal notch then to third inter-costal space) with routine CXR performed and reviewed after insertion. If catheters required repositioning after CXR in either group, time was measured for this additional procedure and added to the total procedure time.
An independent observer documented the procedural time start time (first needle puncture of skin) and conclusion time (the sterile dressing was applied). Procedure room set up and clean up time was not included in timings.
Control group
Active

Outcomes
Primary outcome [1] 324497 0
The primary outcome measure was the proportion of catheters not requiring repositioning (ready for use) after insertion as interpreted on CXR.

This numerator was derived by reviewing the mobile CXR image that was digitally transferred to the patients electronic medical record.
Timepoint [1] 324497 0
Immediately after catheter insertion
Secondary outcome [1] 384812 0
Procedural time from skin puncture with needle to sterile dressing applied.

Achieved by an independent observer noting procedure start time and procedure end time using a digital clock in the procedure room,
Timepoint [1] 384812 0
Immediately after procedure
Secondary outcome [2] 385780 0
Total procedural time (composite of: waiting time for CXR for all patients in traditional anthropometric group and any post insertion re-manipulation time in both groups).

Achieved by an independent observer noting start time when mobile radiographer called for CXR and end time when CXR image reviewed, with catheter in satisfactory position, including after any re-manipulation (defined as catheter ready to use). Time was assessed using a digital clock in the procedure room,
Timepoint [2] 385780 0
Immediately after procedure
Secondary outcome [3] 385781 0
Catheter and consumables required for initial procedure and any subsequent re-manipulations and porter time in both groups

Consumable costs were as per NSW Health state contract pricing (standard CVAD procedure pack and catheter)

Porter time: an independent observer noted porter transfer log in time (start time) and porter pick up time (end time) using a digital clock in the procedure room,
Timepoint [3] 385781 0
Immediately after procedure

Eligibility
Key inclusion criteria
Inclusion criteria were: age of at least 18 years, a native P wave on ECG and ability to provide written informed consent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were: patients less than 18 years, pacemaker dependency or no native P wave on ECG or inability to provide informed consent for themselves or via a responsible person.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocations were computer generated and concealed to investigators and patients until enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated 1:1 ratio - no block randomisation or stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pragmatic, open-label randomised controlled trial using intention to treat analysis
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analysis was undertaken using an intention-to-treat (ITT) approach. The sample size was based on our existing central venous access service catheter malposition rate of 16.75%(23) being reduced to 5% using IC ECG. It was estimated that 163 patients were required in each group for > 90% power. With an estimated 5% attrition rate, 172 patients were randomised in each group (total of 344 patients). Characteristics of study participants, based on allocation to traditional or IC ECG groups are presented using descriptive statistics. All tests were two-sided, with statistical significance set at p<0.05. All data management and analyses were undertaken using the R language for statistical computing, version 3.1.2 (R Core Team Vienna, Austria).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/12/2016
Date of last participant enrolment
Anticipated
Actual
4/07/2018
Date of last data collection
Anticipated
Actual
4/07/2018
Sample size
Target
344
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17128 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 30804 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 306262 0
Commercial sector/Industry
Name [1] 306262 0
Cook Medical Australia
Country [1] 306262 0
Australia
Funding source category [2] 306266 0
Commercial sector/Industry
Name [2] 306266 0
Flo Medical Australia
Country [2] 306266 0
Australia
Funding source category [3] 306267 0
Commercial sector/Industry
Name [3] 306267 0
BARD Access Systems
Country [3] 306267 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital Australia
Address
Corner of Elizabeth and Goulburn Streets, Liverpool New South Wales 2170
Country
Australia
Secondary sponsor category [1] 306750 0
None
Name [1] 306750 0
Address [1] 306750 0
Country [1] 306750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306470 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 306470 0
Ethics committee country [1] 306470 0
Australia
Date submitted for ethics approval [1] 306470 0
23/11/2015
Approval date [1] 306470 0
01/06/2016
Ethics approval number [1] 306470 0
HREC/15/LPOOL/552

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

Contacts
Principal investigator
Name 104002 0
Dr Evan Alexandrou
Address 104002 0
Western Sydney University
Building EB/LG Room 44, Parramatta South Campus
Locked Bag 1797 Penrith NSW 2751 Australia
Country 104002 0
Australia
Phone 104002 0
+61 4 18 453 650
Fax 104002 0
Email 104002 0
E.Alexandrou@westernsydney.edu.au
Contact person for public queries
Name 104003 0
Evan Alexandrou
Address 104003 0
Western Sydney University
Building EB/LG Room 44, Parramatta South Campus
Locked Bag 1797 Penrith NSW 2751 Australia
Country 104003 0
Australia
Phone 104003 0
+61 4 18 453 650
Fax 104003 0
Email 104003 0
E.Alexandrou@westernsydney.edu.au
Contact person for scientific queries
Name 104004 0
Evan Alexandrou
Address 104004 0
Western Sydney University
Building EB/LG Room 44, Parramatta South Campus
Locked Bag 1797 Penrith NSW 2751 Australia
Country 104004 0
Australia
Phone 104004 0
+61 4 18 453 650
Fax 104004 0
Email 104004 0
E.Alexandrou@westernsydney.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
Due to local organisational restrictions, individual participant data will be available on request


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8559Study protocol    380236-(Uploaded-21-07-2020-14-11-21)-Study-related document.docx
8560Ethical approval    380236-(Uploaded-21-07-2020-14-14-21)-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
EmbaseA randomised trial of intracavitary electrocardiography versus surface landmark measurement for central venous access device placement.2023https://dx.doi.org/10.1177/11297298221085228
N.B. These documents automatically identified may not have been verified by the study sponsor.