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. 2021 Oct 12;2021(10):CD013585. doi: 10.1002/14651858.CD013585.pub2

Kim 2021a.

Study characteristics
Methods Single‐centre prospective randomised controlled 2‐arm parallel‐assignment open‐label study
Korea
Duration: 3 March 2017 to 16 November 2017
Participants
  • 76 participants randomised

  • 76 analysed (experimental = 38, comparator = 38), losses not described

  • mean age (years) ± SD: 52.5 ± 15.0 experimental, 50.6 ± 14.1 comparator

  • gender (male/female): 14/24 experimental, 21/17 comparator

  • severity of condition: requiring clinically indicated arterial cannulation, under general anaesthesia

  • comorbidities: not reported

  • BMI (kg/m²): not reported

  • artery of interest: radial

  • diameter (cm), mean ± SD: 3.43 ± 1.23 experimental, 3.57 ± 1.07 comparator

  • catheterisation purpose (experimental/comparator): all for diagnosis (not detailed)


Inclusion criteria
  • adults over 19 years of age required to have an arterial line insertion


Exclusion criteria
  • vascular malformation

  • haemodynamically unstable

  • blood coagulation disorder

  • peripheral arterial occlusive disease

  • reoperation

  • emergency surgery

Interventions Experimental: short‐axis, out‐of‐plane, B‐mode, real‐time ultrasound‐guided puncture
Comparator: short‐axis, out‐of‐plane, B‐mode, real‐time ultrasound‐guided puncture plus electromagnetic guidance
Level of experience of person carrying out the procedure: quote: "arterial cannulation was performed by a single anaesthesiologist who had successfully performed arterial cannulation under electromagnetic ultrasound guidance more than 50 times"
Concomitant medications: all under general anaesthesia
Excluded medications: not reported
Outcomes Primary (specified)
  • percentage of success and vascular wall puncture


Primary (collected)
  • percentage of success and vascular wall puncture


Secondary (specified)
  • adverse events


Secondary (collected)
  • first‐attempt success rate

  • puncture site 

  • cannulation time (seconds)

  • number of attempts 

  • posterior wall puncture

  • haematoma

  • thrombosis


Time points reported: up to 1 day
Notes Funding: quote: "this study was carried out with our departmental funding source. There was no other source of funding except our departmental funding source"
Conflicts of interest: quote: "the authors declare that they have no competing interests"
Protocol available (KCT0002476)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the participants were randomly allocated into two groups using a computerized, randomized table"
Allocation concealment (selection bias) Low risk Quote: "the allocations were concealed in sequentially numbered, sealed, opaque envelopes"
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "the provider could not be blinded because the activation of the electromagnetic guidance system was displayed on the screen"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias)
All outcomes Low risk There were no losses
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported
Other bias Low risk We do not suspect any other bias related to this study