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Catheter securement systems: comparison of two investigational devices to a sutureless securement device, a securement dressing, and sutures in a pig model.

Rutledge LF, DeCabooter DP, Walters SA, Bernatchez SF - Intensive Care Med Exp (2015)

Bottom Line: Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors.Results showed that the two investigational devices displayed the highest mean peak axial pull forces (40-41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test.The two investigational devices appear to be a promising alternative for catheter securement, superior to sutures and the securement dressing, and non-inferior to the securement device.

View Article: PubMed Central - PubMed

Affiliation: Critical & Chronic Care Solutions Division, 3M Company, 3M Center Bldg 270-3A-04, St. Paul, MN, 55144-1000, USA, lfrutledge1@mmm.com.

ABSTRACT

Background: Catheter securement is critical for the success of infusion therapy and to prevent complications. Our purpose was to compare the strength of catheter securement achieved with two investigational adhesive securement devices to two securement products and also to sutures using an in vivo animal model.

Methods: Twenty-five live pigs were prepared for aseptic abdominal surgery. Four central venous catheters were inserted per animal into the epigastric veins and secured with four of the five securement systems studied, following a balanced incomplete randomized block design. A peak axial pull force test method was used to measure the force required to dislodge the catheter 1 cm from the insertion site and/or cause failure of the device and/or dressing. This pull test was done 10 min after device application, per constraints of the animal model. Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors. Non-inferiority testing was carried out using 95 % confidence intervals with a margin of 4.52 N or 1 lb (454 g). Tukey's method was used to adjust for multiple pairwise comparisons.

Results: Results showed that the two investigational devices displayed the highest mean peak axial pull forces (40-41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test. The securement device required a higher mean peak axial pull force than sutures (p = 0.0007) and the securement dressing (p < 0.0001) for failure to occur. Finally, there was also a statistical difference between sutures and the securement dressing, with sutures requiring a higher mean peak axial pull force for catheter dislodgement than the securement dressing (p < 0.0001).

Conclusion: The two investigational devices appear to be a promising alternative for catheter securement, superior to sutures and the securement dressing, and non-inferior to the securement device.

No MeSH data available.


Schematic view of the pig abdomen with two catheters inserted (right cranial, left caudal)
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Fig1: Schematic view of the pig abdomen with two catheters inserted (right cranial, left caudal)

Mentions: In order to provide enough space between securement systems, only two catheters were inserted at one time and placed diagonally from one another, e.g., right cranial and left caudal aspects of the abdomen as illustrated in Fig. 1. The skin where each catheter exited was marked with an indelible skin marker. After the first set of two catheters and securement systems were tested, they were pulled out and the second set of two catheters and securement systems were positioned and tested (left cranial, right caudal).Fig. 1


Catheter securement systems: comparison of two investigational devices to a sutureless securement device, a securement dressing, and sutures in a pig model.

Rutledge LF, DeCabooter DP, Walters SA, Bernatchez SF - Intensive Care Med Exp (2015)

Schematic view of the pig abdomen with two catheters inserted (right cranial, left caudal)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4549365&req=5

Fig1: Schematic view of the pig abdomen with two catheters inserted (right cranial, left caudal)
Mentions: In order to provide enough space between securement systems, only two catheters were inserted at one time and placed diagonally from one another, e.g., right cranial and left caudal aspects of the abdomen as illustrated in Fig. 1. The skin where each catheter exited was marked with an indelible skin marker. After the first set of two catheters and securement systems were tested, they were pulled out and the second set of two catheters and securement systems were positioned and tested (left cranial, right caudal).Fig. 1

Bottom Line: Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors.Results showed that the two investigational devices displayed the highest mean peak axial pull forces (40-41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test.The two investigational devices appear to be a promising alternative for catheter securement, superior to sutures and the securement dressing, and non-inferior to the securement device.

View Article: PubMed Central - PubMed

Affiliation: Critical & Chronic Care Solutions Division, 3M Company, 3M Center Bldg 270-3A-04, St. Paul, MN, 55144-1000, USA, lfrutledge1@mmm.com.

ABSTRACT

Background: Catheter securement is critical for the success of infusion therapy and to prevent complications. Our purpose was to compare the strength of catheter securement achieved with two investigational adhesive securement devices to two securement products and also to sutures using an in vivo animal model.

Methods: Twenty-five live pigs were prepared for aseptic abdominal surgery. Four central venous catheters were inserted per animal into the epigastric veins and secured with four of the five securement systems studied, following a balanced incomplete randomized block design. A peak axial pull force test method was used to measure the force required to dislodge the catheter 1 cm from the insertion site and/or cause failure of the device and/or dressing. This pull test was done 10 min after device application, per constraints of the animal model. Comparison analysis was carried out using a mixed effects model with pig, sample, and sample location as factors. Non-inferiority testing was carried out using 95 % confidence intervals with a margin of 4.52 N or 1 lb (454 g). Tukey's method was used to adjust for multiple pairwise comparisons.

Results: Results showed that the two investigational devices displayed the highest mean peak axial pull forces (40-41 N) and were significantly better than sutures (28 N, p < 0.0001) and the securement dressing (17 N, p < 0.0001) and non-inferior to the securement device (37 N) in this test. The securement device required a higher mean peak axial pull force than sutures (p = 0.0007) and the securement dressing (p < 0.0001) for failure to occur. Finally, there was also a statistical difference between sutures and the securement dressing, with sutures requiring a higher mean peak axial pull force for catheter dislodgement than the securement dressing (p < 0.0001).

Conclusion: The two investigational devices appear to be a promising alternative for catheter securement, superior to sutures and the securement dressing, and non-inferior to the securement device.

No MeSH data available.