Kiberenge 2018.
Study characteristics | ||
Methods | Single‐centre prospective randomised controlled 2‐arm parallel‐assignment single‐blinded (outcomes assessor) study USA Duration: May 2015 to December 2015 |
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Participants |
Inclusion criteria
Exclusion criteria
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Interventions | Experimental: ultrasound‐guided RA puncture (real‐time, artery short axis, needle out‐of‐plane, DNTP) Comparator: RA puncture via palpation and landmarks Level of experience of person carrying out the procedure: quote: "arterial cannulation was performed by anaesthesia residents or faculty members" and "the operators (anesthesia residents, fellows, and faculty) placing the arterial catheters were required to have placed at least 10 radial arterial catheters using each technique prior to participation in the study" Outcome data were reported separately by experienced and inexperienced operators Concomitant medications: quote: "arterial cannulation was performed either before or after induction of general anesthesia based on the preference of the faculty anesthesiologist" Excluded medications: not reported |
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Outcomes | Primary (specified)
Primary (collected)
Secondary (specified)
Secondary (collected)
Time points reported: up to 5 minutes |
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Notes | Funding: University of Iowa Hospitals and Clinics Conflicts of interest: quote: "the authors declare no conflicts of interest" Protocol (NCT02557828) available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the assignments were computer generated, with randomly selected block sizes using nQuery Advisor 7.0 (Statistical Solutions Ltd, Cork, Ireland) and then placed in sealed envelopes" |
Allocation concealment (selection bias) | Low risk | Quote: "the technique to be used for cannulation was determined when the research team member opened an opaque randomization envelope containing a piece of paper with either ultrasound or palpation printed on it" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding for participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Protocol states that this was an 'outcomes assessor' blinding study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no losses |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. Protocol violations were reported and were treated in an ITT analysis Quote: "there were 3 protocol violations: one was due to the use of a different catheter, one operator refused to use the palpation technique after randomization, and another used a wire to guide the catheter into the vessel lumen while using the dynamic needle tip positioning technique. These 3 patients were treated as failed attempts in the intention to treat analysis" |
Other bias | Low risk | We do not suspect any other bias related to this study |