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

Khan 2018.

Study characteristics
Methods [Abstract of event] Single‐centre prospective randomised controlled 2‐arm parallel‐assignment open‐label study
India
Duration: not reported
Participants
  • 100 participants randomised, (experimental = 49, comparator = 51)

  • 100 participants analysed

  • mean age (years) ± SD: not reported

  • gender (male/female): not reported

  • severity of condition (experimental/comparator): critically ill participants

  • comorbidities (experimental/comparator): not reported

  • body weight (kg): not reported

  • height (cm): not reported

  • artery of interest: radial

  • diameter (mm), mean ± SD: not reported

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


Inclusion criteria
  • aged > 18 years

  • hypotension (or requiring vasopressor infusion)

  • no previously cannulated radial artery


Exclusion criteria
  • deformity or local trauma or local infection at arterial cannulation site

  • severe coagulopathy (platelets < 30,000/mm³ and/or INR > 2.0)

  • non‐palpable radial pulse

  • radial artery already cannulated previously

  • negative Barbeau test

Interventions Experimental: ultrasound‐guided RA puncture (real‐time; artery short axis; needle in out‐of‐plane)
Comparator: RA puncture via palpation and landmarks
Level of experience of person carrying out the procedure: not reported
Concomitant medications: not reported
Excluded medications: not reported
Outcomes Primary (specified)
  • first‐pass success rate


Primary (collected)
  • first‐pass success rate


Secondary (specified)
  • final success rate

  • total number of attempts needed for catheterisation

  • time for successful catheterization (cannulation time)

  • total time taken in the procedure

  • failure rate

  • number of catheters used

  • posterior wall haemorrhage

  • haematoma

  • incidence of spasm and other complications

  • cross‐over to either technique


Secondary (collected)
  • cannulation time

  • rate of early complications


Time points reported: up to the end of the procedure
Notes Funding: not reported
Conflicts of interest: not reported
Protocol (CTRI/2017/03/008020) available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "computer generated randomization"
Allocation concealment (selection bias) High risk Quote: "an open list of random numbers"
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias)
All outcomes High risk Open‐label study
Incomplete outcome data (attrition bias)
All outcomes Unclear risk There were no losses. The account of cross‐over to either intervention was planned but was not reported
Selective reporting (reporting bias) High risk Some data (final success rate, time for successful catheterisation (cannulation time), posterior wall haemorrhage, haematoma, incidence of spasm and other complications, cross‐over to either technique) of interest for this review were planned in the trial protocol but were not reported or were reported incompletely (cannulation time)
Other bias Low risk We do not suspect any other bias related to this study