A 4-arm randomized controlled pilot trial of innovative solutions for jugular central venous access device securement in 221 cardiac surgical patients

作者：Rickard C M^*; Edwards M; Spooner A J; Mihala G; Marsh N; Best J; Wendt T; Rapchuk I; Gabriel S; Thomson B; Corley A; Fraser J F

来源：Journal of Critical Care, 2016, 36: 35-42.

DOI：10.1016/j.jcrc.2016.06.006

• Vascular access devices
• Occlusive dressings
• Randomized controlled trial
• Securement device
• Tissue adhesives

Purpose: To improve jugular central venous access device (CVAD) securement, prevent CVAD failure (composite: dislodgement, occlusion, breakage, local or bloodstream infection), and assess subsequent trial feasibility.
Materials and Methods: Study design was a 4-arm, parallel, randomized, controlled, nonblinded, pilot trial. Patients received CVAD securement with (i) suture + bordered polyurethane (suture + BPU; control), (ii) suture + absorbent dressing (suture + AD), (iii) sutureless securement device + simple polyurethane (SSD + SPU), or (iv) tissue adhesive + simple polyurethane (TA + SPU). Midtrial, due to safety, the TA + SPU intervention was replaced with a suture + TA + SPU group.
Results: A total of 221 patientswere randomized with 2 postrandomization exclusions. Central venous access device failure was as follows: suture + BPU controls, 2 (4%) of 55 (0.52/1000 hours); suture + AD, 1 (2%) of 56 (0.26/1000 hours, P =.560); SSD + SPU, 4 (7%) of 55 (1.04/1000 hours, P =.417); TA + SPU, 4 (17%) of 23 (2.53/1000 hours, P =.049); and suture + TA + SPU, 0 (0%) of 30 (P =.263; intention-to-treat, log-rank tests). Central venous access device failure was predicted (P <.05) by baseline poor/fair skin integrity (hazard ratio, 9.8; 95% confidence interval, 1.2-79.9) or impaired mental state at CVAD removal (hazard ratio, 14.2; 95% confidence interval, 3.0-68.4).
Conclusions: Jugular CVAD securement is challenging in postcardiac surgical patients who are coagulopathic and mobilized early. TA + SPU was ineffective for CVAD securement and is not recommended. Suture + TA + SPU appeared promising, with zero CVAD failure observed. Future trials should resolve uncertainty about the comparative effect of suture + TA+ SPU, suture + AD, and SSD + SPU vs suture + BPU.

• 出版日期2016-12