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
627 Rode Road
Chermside QLD 4032
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
RESEARCH AIMS AND HYPOTHESIS

The insertion of radial artery catheters for continuous measurement of blood pressure, as well as easy and regular sampling of blood, is a ubiquitous technique in critical care settings such as the intensive care unit and operating theatre. The radial artery is the preferred site of access due to its anatomic consistency and accessibility, relative ease of cannulation compared with other sites and the low complication rate. In 1990 the number of arterial catheters placed perioperatively was estimated to be 8 million in the United States and 2.5 million in Europe – and this number will only grow as the complexity of patients increases. Despite the ease with which some arterial lines are placed, there are numerous cases in which the operator struggles to obtain appropriate and timely access or causes complications such as bleeding, hematoma formation, psuedoaneurysm, infection, nerve damage, distal limb ischemia, temporary arterial spasm and occlusion, digital embolization / ischemia and patient discomfort.

There is currently limited research into arterial line placement at the radial artery using ultrasound in the adult perioperative patient population. This study will evaluate the application of ultrasound guidance to radial artery cannulation in comparison with the traditional palpation technique in the adult cardiothoracic surgical population. The hypothesis of this study is that there will be a difference between the two techniques in time to successful cannulation, number of attempts before successful placement, number of cannulae used, and number of puncture sites per patient. The hypothesis is that this difference will favour ultrasound guidance. In addition, there has never been a cost-analysis performed on the use of ultrasound guidance for radial arterial line placement in comparison to the traditional technique in any population, and this will also be carried out.
Trial website
Trial related presentations / publications
Public notes
LITERATURE FOUDNATIONS AND BACKGROUND

The proliferation and availability of small, mobile ultrasound machines has led to an increased use beyond the traditional diagnostic area. Anaesthetists now use ultrasound for a wide variety of procedures – such as vascular access, regional and central neural blockade, and scanning of the lungs and heart. A large amount of evidence exists on ultrasound use in obtaining intravenous access both peripherally and centrally. The evidence states that using real-time ultrasound for central venous access increases first-pass and overall success rate, requires fewer attempts and reduces time to successful cannulation, reduces the incidence of complications and helps improve patient outcome. As ultrasound is being used frequently for intravenous access, there is also increased experience and interest in the use of ultrasound guidance for arterial cannulation. A large multi-centre study of 1004 patients compared real-time ultrasound guided femoral artery cannulation with a landmark/palpation approach, and demonstrated that although overall success rate was similar between the two groups ultrasound increased first-pass success while decreasing the number of attempts, time to successful cannulation and complication rate. There are numerous other studies with a large number of total patients that show the effectiveness of ultrasound for femoral artery cannulation in various vascular procedures. A meta-analysis on radial artery cannulation included 4 prospective, randomized controlled trials comparing real-time ultrasound guidance with palpation, and demonstrated an increased likelihood of successful cannulation on first attempt of 71% over palpation (relative risk, 1.17; 95% confidence interval 1.25-2.32).

Despite the plethora of data on ultrasound improving the practice of obtaining intravenous access, there is surprisingly little data on the use of ultrasound for radial arterial access. The aforementioned meta-analysis on ultrasound use for radial artery cannulation contained 4 studies and only 311 total patients. Of these 311 total patients, 30 were small children with an average age of 40 months old, 152 were paediatric surgical patients between the ages of 2 and 14, 60 were adult emergency department patients and 69 were adult surgical patients. Therefore, only 69 (22%) of the patients in this meta-analysis are relevant to the practice of adult anaesthesia and intensive care, and the inclusion of both adult and paediatric populations in different clinical scenarios weakens the outcome measures in the meta-analysis due to heterogeneity of trials and the relatively small number of patients available for total analysis. Our goal is to carry out a focused, well-designed study, with large numbers of patients to ensure adequate study power, in a patient cohort that is relevant to the practice of medicine at TPCH and the use of ultrasound in the wider general population.



METHODOLOGY AND RESEARCH PLAN

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. The data to be collected is itemized in the section “Outcome Measures” below.

Setting: The Prince Charles Hospital (TPCH) in Brisbane, Queensland. TPCH is the regional referral centre for the state of Queensland and northern New South Wales and undertakes surgery for all cardiac conditions including bypass surgery, valve surgery, ventricular assist device surgery, extra-corporeal membrane oxygenation, and heart and lung transplantation. Additionally, it has an active cardiology service performing numerous percutaneous aortic valve implantations. The study will be performed in the operating theatre of TPCH. Institutional ethics review board approval for the study protocol and performance will be obtained prior to starting the study. This study is pertinent to care to patients at TPCH, as a large percentage of patients that are cared for at TPCH are identical to the population being studied. In addition, as this study will be the largest of its kind in the literature, and the most specific and focused on the patient population commonly requiring intra-arterial access, it will be highly visible within the anaesthetic and medical communities. The TPCH has a large population of patients who present for cardiac and vascular surgery. These patients often have comorbid vascular disease of their peripheral vascular system, and as such are difficult subjects on which to obtain peripheral arterial access. The elderly patients in question often have small, calcified vessels and have known arterial disease throughout their vascular tree. This patient population is an ideal group to study for this type of procedure, as they are the patient group most likely to benefit from the use of ultrasound guidance for arterial access.

Participants & Study Population: 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. 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. 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.

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 (as defined in the “Participants” section) 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.


Outcome Measures: The outcome measures that will be collected are:
- Number of attempts required for successful placement
- Total time required for successful placement
- Time taken from skin puncture to successful placement
- Number of new skin penetrations required for successful placement
- Number of body sites required for successful placement
- Number of cannulae used
- Requirement of another anaesthetist for help or guidance
- Requirement of ultrasound guidance to obtain successful placement if difficulty is reached during the traditional blind palpation method
- 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
- Patient satisfaction and pain rating regarding procedure
- Non-identifiable demographic information as described earlier.

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).


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.


Ethics: Approval of the institutional review board will be obtained prior to beginning the study. Each patient will require informed written consent, and each patient will be non-identifiable. In general, there should be no difficulty in obtaining ethical approval, as each patient requires an arterial line regardless of study entrance, and the requirement of ultrasound guidance is well known in vascular procedures - and already used in some difficult cases. Additionally, there are few if any disadvantages or complications associated with using ultrasound for arterial cannulation compared to the blind palpation technique. Nonetheless, all patients will be consented, and all anaesthetic providers will receive an information sheet documenting their participation and addressing any concerns.

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
Dr 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
Dr 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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