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

Rickard, C. M., Edwards, M., Spooner, A. J., Mihala, G., Marsh, N., Best, J., Wendt, T., Rapchuk, I., Gabriel, S., Thomson, B., Corley, A. and Fraser, J. F. (2016) A 4-arm randomized controlled pilot trial of innovative solutions for jugular central venous access device securement in 221 cardiac surgical patients. Journal of Critical Care, 36 35-42. doi:10.1016/j.jcrc.2016.06.006

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Author 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.
Title A 4-arm randomized controlled pilot trial of innovative solutions for jugular central venous access device securement in 221 cardiac surgical patients
Journal name Journal of Critical Care   Check publisher's open access policy
ISSN 1557-8615
0883-9441
Publication date 2016-12-01
Sub-type Article (original research)
DOI 10.1016/j.jcrc.2016.06.006
Open Access Status File (Author Post-print)
Volume 36
Start page 35
End page 42
Total pages 8
Place of publication Maryland Heights, MO, United States
Publisher W.B. Saunders
Collection year 2017
Language eng
Formatted abstract
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 patients were 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.
Keyword Occlusive dressings
Randomized controlled trial
Securement device
Tissue adhesives
Vascular access devices
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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