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ID
Source
Brief title
Health condition
cardiac disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
first pass success rate
Secondary outcome
scan time, needling time, procedure time, number of attempts, number of needle redirection, operator satisfaction, needle visibility, complications
Background summary
Rationale: Arterial cannulation for continuous invasive blood pressure monitoring and blood sampling is a standard procedure for patients undergoing major abdominal or cardiothoracic surgery. Traditionally performed by digital palpation, ultrasound (US) is increasingly used for this procedure. However, US guidance marginally increases success rates for this procedure. As US techniques can be performed in short or long axis, both approaches have their shortcomings. Using three dimensional biplanar US, both short and long axis views can be displayed simultaneously. We hypothesize the additional information of the anatomical site will improve radial artery cannulation success rate.
Objective: Compare performance of radial artery catheterization using three dimensional biplanar ultrasound guidance versus conventional two dimensional US
Study design: Prospective randomized controlled trial
Study population: Adult patients >18 years, requiring scheduled cardiothoracic surgery for which radial artery catheterization is required
Intervention: Radial artery cannulation using three dimensional biplanar US guidance
Main study parameters/endpoints: First pass success rate, scan time, needling time, procedure time, number of skin punctures, number of needle redirections, complications including posterior wall puncture, and hematoma, needle visibility, operator satisfaction
Study objective
3D guided arterial cannulation increases first pass success rate and decreases punctures
Study design
February 2022: analysis of primary and secondary endpoints,The primary endpoint, first pass success, will be compared between the group where 3D US is used, compared to the 2D US group, using a chi square test. Regarding secondary study parameters, for continuous variables, distribution of data will be assessed for normality. If a normal distribution is found, a parametric t-test will be used. If the data is not normally distributed, a mann whitney u test will be used. Categorical data will be analysed using a chi squared test. Fisher’s exact test will be used for data with small sample sizes.
Inclusion criteria
adult patient, elective cardiothoracic surgery requiring radial artery cannulation
Exclusion criteria
no informed consent, anatomical abnormalities at access site,or other site of arterial access
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9687 |
CCMO | NL78704.100.21 |
OMON | NL-OMON50629 |