McCarthy 2016C.
Study characteristics | ||
Methods | Randomised, open‐label trial | |
Participants | Setting: ED Number of participants: 596 (USG 305, LM 291) Age, mean (SD) years: not specified Difficulty: easy (could see or palpate at least 1 vein and thought IV access would be easy with LM) Sites of peripheral veins: upper extremity | |
Interventions |
Technique
LM vs USG:
Machine: Sonosite M‐Turbo (Sonosite) or Zonare ultra (Zonare)
Axis: not specified
Guidance: dynamic Operator Profession: technician Number of operators: 33 Experience of USG before the study: yes Length of experience with USG before the study: 82% of the operators had more than one year of experience A training programme of USG for the study: yes Number of clinical cases with USG required or experienced before the study intervention started: not specified Needle Length: 32 or 48 mm Gauge: 18 ‐ 22 |
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Outcomes | First‐pass success of cannulation, procedure time for first‐pass cannulation, pain, complications Definition of successful cannulation: smooth normal saline flush, and no signs of extravasation Definition of start and end of time measurement
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Funding | Award K01HS017957 from the Agency for Healthcare Research and Quality | |
Declarations of interest | None declared | |
Notes | McCarthy 2016 randomised participants separately according to the difficulty of the LM (easy, moderate, and difficult), and we split them according to the difficulty level (McCarthy 2016A; McCarthy 2016B; McCarthy 2016C) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation scheme was created by SAS software (version 9.3; SAS Institute Inc., Cary, NC) |
Allocation concealment (selection bias) | Low risk | Centrally randomised with REDCap (version 6.5.12; Nashville, TN) |
Blinding (performance bias and detection bias) First‐pass success of cannulation | Low risk | Although blinding of participants and operators is impossible due to the nature of the intervention, a third person assessed the outcome |
Blinding (performance bias and detection bias) Pain | High risk | Although a third person assessed the outcome, participants were not blinded and the outcome could be influenced by subjectivity |
Blinding (performance bias and detection bias) Procedure time for first‐pass cannulation | Low risk | Although blinding of participants and operators is impossible due to the nature of the intervention, a third person assessed the outcome |
Blinding (performance bias and detection bias) Overall complications | Low risk | Although blinding of participants and operators is impossible due to the nature of the intervention, a third person assessed the outcome |
Incomplete outcome data (attrition bias) First‐pass success of cannulation | Low risk | There were only 5 dropouts (USG 5) out of 305 participants |
Incomplete outcome data (attrition bias) Pain | Low risk | There were only 4 dropouts out of 1189 participants across the whole study |
Incomplete outcome data (attrition bias) Procedure time for first‐pass cannulation | Low risk | There were only 7 dropouts out of 1189 participants across the whole study |
Incomplete outcome data (attrition bias) Overall complications | Low risk | The outcome was available for all participants |
Selective reporting (reporting bias) | Low risk | The outcomes reported in the article were consistent with the trial registry (NCT01859559) |
Other bias | Low risk | No concerns about other sources of bias |
Overall risk First‐pass success of cannulation | Low risk | All domains were at low risk |
Overall risk Pain | High risk | At least one domain was at high risk |
Overall risk Procedure time for first‐pass cannulation | Low risk | All domains were at low risk |
Overall risk Overall complications | Low risk | All domains were at low risk |