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

Tangwiwat 2016.

Study characteristics
Methods Single‐centre prospective randomised controlled 2‐arm study, with blinding not described
Thailand
Duration: November 2009 to October 2010
Participants
  • 100 participants randomised (experimental = 30, comparator = 30)

  • 100 participants analysed

  • mean age (years) ± SD: 51.0 ± 15.3 experimental, 50.4 ± 15.1 comparator

  • gender (male/female): 20/30 experimental, 19/31 comparator

  • severity of condition (experimental/comparator): all participants undergoing neurosurgery, ASA 1 (4/3), ASA 2 (36/41), ASA 3 (10/6)

  • comorbidities (experimental/comparator): number of patients intubated 22/23

  • body weight (kg): not reported

  • height (cm): not reported

  • artery of interest: radial

  • diameter (mm), mean ± SD: not reported. Catheter size 20 G

  • catheterisation purpose (experimental/comparator): all for diagnosis (pressure monitoring or blood test, % not reported, during neurosurgery)


Inclusion criteria
  • undergoing neurosurgery

  • >18 years old

  • indication for radial artery cannulation


Exclusion criteria
  • pregnant women

  • negative modified Allen’s test

  • severe vascular morbidity such as limb ischaemia from multiple insertion attempts and air emboli

Interventions Experimental: ultrasound‐guided RA puncture (real‐time, artery short axis, out‐of‐plane)
Comparator: RA puncture by palpation and landmarks
Level of experience of person carrying out the procedure: quote: "ten third‐year residents, having performed USG vascular catheterization as yet less than 3 times"
Concomitant medications: not reported
Excluded medications: not reported
Outcomes Primary (specified)
  • time to placement

  • number of attempts

  • sites used

  • success rate

  • complications (haematoma, infection, retained catheter, radial nerve damage, arterial thrombosis/ischaemia, carpal tunnel syndrome)


Primary (collected)
  • success rate in first attempt

  • time to placement

  • number of attempts

  • sites used

  • success rate

  • complications (haematoma)


Secondary (specified)
  • no differentiation between primary and secondary outcomes


Secondary (collected)
  • no differentiation between primary and secondary outcomes


Time points reported: up to 24 hours
Notes Funding: quote: "this work was supported by Siriraj Research Development Fund, Faculty of Medicine Siriraj Hospital, Mahidol University"
Conflicts of interest: quote: "none"
Protocol not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using computer generated block randomization (mixed block size)"
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described, but due to the nature of the interventions, we assumed that blinding of personnel was not possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias)
All outcomes High risk There was an imbalance in cross‐over interventions between experimental (6/50) and comparator (1/50) groups
Selective reporting (reporting bias) High risk Some of the planned safety outcomes were not reported (infection, retained catheter, radial nerve damage, arterial thrombosis/ischaemia, carpal tunnel syndrome)
Other bias Low risk We do not suspect any other bias related to this study