Methods |
Study design: Randomised Controlled Trial. Object of randomisation: procedures. Two intervention arms and one control arm |
Participants |
France. Anaesthetist physicians and anaesthetist nurses in the operating room and emergency performing IV infusion. Number studied: 759 procedures. Intervention group one n = 251, Control group n = 254 (divided over the two arms). |
Interventions |
Arm 1: use of passive safety catheter (Introcan Safety). Intervention 2: use of active safety catheter (Insyte Autoguard). Control group used the Vialon non‐safety catheter. We divided the control group over the two intervention arms. |
Outcomes |
1. Number of cases in which the patient's blood stained the operator's skin, gloves, mask, or any other clothing; 2. Number of cases in which the patient's blood stained the stretcher or floor. Secondary outcome: Ease of use and sense of protection. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"the type of venous catheter to use was determined randomly in a three ball ballot box." |
Allocation concealment (selection bias) |
Low risk |
"The choice of the catheter was randomised by using a single blinded envelope method" |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No information on blinding available. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No information reported about the number of excluded patients. |
Selective reporting (reporting bias) |
Low risk |
"If the operator considered the patient's vein unsuitable for placing an 18 G catheter, the patient was excluded from the protocol" |
Similar recruitment of groups |
Low risk |
Not reported but adequate randomisation to the control or intervention group. |
Adjustment for baseline differences |
Low risk |
Adequate randomisation, no additional adjustment needed in the analysis. |
Other bias |
Low risk |
The study appears to be free of other types of bias. |