Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000561684
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
27/05/2014
Date last updated
27/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective evaluation of the utility of ultrasound guided radial artery cannulation versus the traditional blind palpation technique in adult cardiac surgical patients. The ULTRA-ART Study.
Scientific title
A prospective evaluation of the utility of ultrasound guided radial artery cannulation versus the traditional blind palpation technique in adult cardiac surgical patients over the age of 18. The ULTRA-ART Study.
Secondary ID [1] 284594 0
nil
Universal Trial Number (UTN)
U1111-1156-7852
Trial acronym
ULTRA-ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intravascular catheter placement 291892 0
Condition category
Condition code
Anaesthesiology 292235 292235 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research Plan Synopsis and Design: This is a prospective, randomized study design comparing the use of out-of-plane ultrasound guidance to the traditional palpation method for placement of radial arterial lines in the adult elective cardiothoracic surgical population at a large academic single centre in Australia. All eligible patients undergoing cardiac or thoracic surgery at TPCH will be included to reach the total number of 328 patients.

Either senior trainees in anaesthesia or the consultant anaesthetist for each case will place the arterial lines. All registrars and faculty are familiar with the ultrasound for use in vascular access (both central and peripheral venous cannulation). However for completeness - prior to study initiation - all senior registrars and anaesthetic consultants involved in arterial line placement will be given a short (10 minute) didactic instruction on ultrasound use for arterial line placement, and it will be assured that all persons undertaking the procedure have completed greater than 25 total arterial line placements in the past, 5 of which must have been done under ultrasound guidance. Currently, arterial lines are not routinely placed under ultrasound guidance in the operating theatre.


Intervention and Procedures: Study anaesthetists will use a Sonosite M-turbo ultrasound system (Bothell, WA, USA) with an HFL-38E 6-13 MHz linear array transducer. An observer with a stopwatch will time how long the physician took to achieve successful placement. In the ultrasound group, time zero will be defined as the time the ultrasound machine is turned on (before gel is applied to the transducer and before a sterile cover is applied). For the blind palpation group time zero will be defined as the time the operator’s fingers are placed on the wrist to palpate the radial pulse to guide needle placement. In addition, for both techniques, a second time record will be started at the point the needle enters skin. The time of placement will end when the catheter has successfully been placed into the vessel with appropriate pulsatile blood return and waveform presence. Data will be collected on a standardized data sheet.

Patients will be randomly assigned to either the ultrasound guided or blind palpation group by using a randomly generated list of allocations. The random allocations will be kept in sequentially numbered sealed envelopes in a locked / secure area, and will be removed one at a time. A standard 20 gauge arterial leader-cath (Vygon Corporation, Montgomeryville, PA, USA) arterial access catheter will be used for all access procedures. The palpation technique will be performed in the classic and standard manner by using the radial artery pulsation as a guide. The ultrasound technique will consist of applying the ultrasound transducer to the skin and using the ultrasound image to locate the target vessel in the short axis – the artery being identified by lack of compression compared to the surrounding veins, pulsatility, and use of colour Doppler if necessary. The ultrasound will be covered with a large tegaderm in a sterile manner, sterile gel will be used to maintain infectious precautions, and the arterial line will be placed with an in-plane ultrasound approach. As a number of the patients in this population can be difficult arterial access, we will limit the number of attempts to three completely new attempts per patient (defined as a distinctly new and purposeful penetration of the skin with the needle, followed by unlimited needle redirections in the skin). A new kit will not be needed for each separate attempt. A new site is defined as moving to the other wrist or another backup location. If failure occurs using the technique to which the patient is randomized (3 attempts without success), either technique can be used as a rescue technique.




Data Collection: The data will be prospectively collected on structured forms to avoid the obvious concerns with retrospective analysis or database assessment. A trained research assistant will be present in the operating theatre during the placement of the arterial catheter, and will obtain all the measurements in a controlled and consistent manner. Demographic data will be collected on all patients. Additionally, all patients will be followed up for 24 hours to assess the secondary endpoints mentioned above (such as swelling, bruising, dressing changes, satisfaction, etc).



Project Schedule: This project will begin once ethical approval is obtained, and will continue for approximately 9 months. It will take 3 months for ethical approval and study set up, 7 months to carry out the study, and 2 months for statistical analysis.
Intervention code [1] 289366 0
Treatment: Devices
Comparator / control treatment
The control treatment is the placement of an arterial line by blind palpation without the use of ultrasound.
Control group
Active

Outcomes
Primary outcome [1] 292107 0
Time to placement of arterial intravascular catheter

Study anaesthetists will use a Sonosite M-turbo ultrasound system (Bothell, WA, USA) with an HFL-38E 6-13 MHz linear array transducer. An observer with a stopwatch will time how long the physician took to achieve successful placement. In the ultrasound group, time zero will be defined as the time the ultrasound machine is turned on (before gel is applied to the transducer and before a sterile cover is applied). For the blind palpation group time zero will be defined as the time the operator’s fingers are placed on the wrist to palpate the radial pulse to guide needle placement. In addition, for both techniques, a second time record will be started at the point the needle enters skin. The time of placement will end when the catheter has successfully been placed into the vessel with appropriate pulsatile blood return and waveform presence. Data will be collected on a standardized data sheet.
Timepoint [1] 292107 0
at time of catheter placement
Secondary outcome [1] 308210 0
number of attempts at placement of intra-arterial catheter
Timepoint [1] 308210 0
number of attempts at placement of intra-arterial catheter at the time of intra-arterial catheter placement.
Secondary outcome [2] 308285 0
Number of attempts required for successful placement
Timepoint [2] 308285 0
at time of initial placement
Secondary outcome [3] 308286 0
Number of new skin penetrations required for successful placement
Timepoint [3] 308286 0
at time of initial line placement
Secondary outcome [4] 308287 0
Number of body sites required for successful placement
Timepoint [4] 308287 0
at time of initial line placement
Secondary outcome [5] 308288 0
Number of cannulae used
Timepoint [5] 308288 0
at time of initial placement
Secondary outcome [6] 308289 0
Requirement of another anaesthetist for help or guidance
Timepoint [6] 308289 0
at time of initial placement
Secondary outcome [7] 308290 0
Requirement of ultrasound guidance to obtain successful placement if difficulty is reached during the traditional blind palpation method
Timepoint [7] 308290 0
at time of initial placement
Secondary outcome [8] 308291 0
Complications: arterial laceration or thrombosis, site hematoma, bruising of patient arm, local swelling, leaking or oozing from puncture site(s), number of dressing changes required
Timepoint [8] 308291 0
at time of initial placement and post operatively for 24 hours
Secondary outcome [9] 308292 0
Patient satisfaction and pain rating regarding procedure. Patient assessment will be performed by using a likert scale questionnairre and pain during the procedure will be assessed using a 10 point VAS.
Timepoint [9] 308292 0
at 24 hours post placement

Eligibility
Key inclusion criteria
The population studied will be all patients 18 years of age or older who are undergoing cardiac or thoracic surgery and are deemed to require an arterial line for clinical indications by the treating medical / surgical team. All patients undergoing cardiac surgery, as well as open thoracotomy, routinely have arterial lines placed for continuous blood pressure monitoring and frequent blood gas analysis. All patients will be non-identifiable, although demographic data on each patient (e.g. height, weight, BMI, age, sex, procedure, blood pressure at time of insertion, presence of arrhythmia) will be collected to allow analysis of possible differences between the study groups.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous attempts at arterial cannulation during the same hospital visit as well as unstable patients in whom the arterial line has to be placed prior to study randomization will be excluded.

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)
Patients will be randomly assigned to either the ultrasound guided or blind palpation group by using a randomly generated list of allocations. The random allocations will be kept in sequentially numbered sealed envelopes in a locked / secure area, and will be removed one at a time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly assigned to either the ultrasound guided or blind palpation group by using a randomly generated list of allocations. Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). The random allocations will be kept in sequentially numbered sealed envelopes in a locked / secure area, and will be removed one at a time.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data Analysis: The number of successful attempts will be compared between groups. Comparison of successful placement rates on first attempt between the ultrasound guided group and the palpation group will be made by using Fisher’s exact test. To compare the number of attempts required to successfully place the arterial line, and the number of anatomic sites required, the Mann-Whitney test will be used. We should not need to adjust for confounders because of the randomized design. We will compare the baseline characteristics of the two randomized groups using frequencies and summary statistics.


Sample Size Calculation: The sample size calculation is based on the comparison between number of attempts – with a comparison between those patients that required multiple (2 or more) attempts at insertion of the arterial catheter as the primary outcome. In a recent study by the same investigators (SAVE -) 30/217 (13.8%) blind palpation radial artery cannulations had 2 or more attempts. Our hypothesis is that the use of ultrasound can halve this rate to 7%, and that we could demonstrate this to a power of 80% with 164 patients per arm. This assumes a two-sided 5% statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
1/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
328
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2459 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 8116 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 289226 0
Charities/Societies/Foundations
Name [1] 289226 0
The Prince Charles Hospital Foundation
Country [1] 289226 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
627 Rode Road
Chermside QLD 4032
Country
Australia
Secondary sponsor category [1] 287897 0
None
Name [1] 287897 0
Address [1] 287897 0
Country [1] 287897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290994 0
The Prince Charles Hospital HREC
Ethics committee address [1] 290994 0
Ethics committee country [1] 290994 0
Australia
Date submitted for ethics approval [1] 290994 0
Approval date [1] 290994 0
09/05/2013
Ethics approval number [1] 290994 0
HREC/13/QPCH/99

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

Contacts
Principal investigator
Name 48342 0
Dr Ivan Rapchuk
Address 48342 0
The prince Charles Hospital
Rode Road
Chermside QLD 4032
Country 48342 0
Australia
Phone 48342 0
+61 7 3139-4000
Fax 48342 0
Email 48342 0
[email protected]
Contact person for public queries
Name 48343 0
Ivan Rapchuk
Address 48343 0
The prince Charles Hospital
Rode Road
Chermside QLD 4032
Country 48343 0
Australia
Phone 48343 0
+61 7-3139-4000
Fax 48343 0
Email 48343 0
[email protected]
Contact person for scientific queries
Name 48344 0
Ivan Rapchuk
Address 48344 0
The prince Charles Hospital
Rode Road
Chermside QLD 4032
Country 48344 0
Australia
Phone 48344 0
+61 7-3139-4000
Fax 48344 0
Email 48344 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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