In Vitro Effectiveness Evaluation of Simulated

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a Novel Closed Suction System with Balloon Sweeping Technology ... been shown to lead to an increase in airflow resistance.ii Consequently, endotracheal.
In Vitro Effectiveness Evaluation of Simulated Secretion Removal Using a Novel Closed Suction System with Balloon Sweeping Technology Study data interpreted by Dr. Stephen Luney, Medical Director, Teleflex Medical Incorporated

Background: During mechanical ventilation pulmonary secretions can accumulate inside the endotracheal tube (ETT),i resulting in a reduced inner diameter of the ETT. Because flow within the lumen of the ETT is proportional to the fourth power of the radius of the tube, even small reductions in ETT diameter have been shown to lead to an increase in airflow resistance.ii Consequently, endotracheal suctioning is routinely employed to help manage possible airway obstructions and has traditionally involved the aspiration of pulmonary secretions from a patient’s artificial airway.iii A traditional closed suction catheter employs suction from only the distal tip and lateral suction ports on the catheter. CleanSweep® Closed Suction System employs dual operation of in-line suction collection and balloon sweeping technology, which has been shown to decrease mechanical airway resistance.iv

Purpose: The primary objective of this in vitro study was to compare the effectiveness of the new Teleflex CleanSweep Closed Suction System device versus traditional closed suction catheters in the removal of simulated ETT secretions.

Method:

Table 1. Weight of the removed simulated secretions*

The efficacy of secretion removal of the CleanSweep Closed Suction System device compared to a traditional closed suction system was evaluated using a benchtop model and simulated secretions. Briefly, 3 mL of simulated secretions were introduced into a 7.0 mm ETT. The weight of the ETT was collected before and after the introduction of the simulated secretions. Next, a 10 French closed suction catheter was attached to the end of the ETT and to a vacuum source. This size catheter was selected as a worst case scenario due to its small diameter compared to the ETT. The closed suction catheter was introduced into the ETT stopping at its distal tip, and then retracted over a period of 15 seconds while activating either the suction (traditional catheter) or suction and balloon wiping (CleanSweep Closed Suction System). After the completion of the 15 second suction pass, the closed suction catheter was disconnected from the ETT and the weight of the ETT after cleaning was measured. The difference in weight of the ETT before and after the cleaning procedure was used to calculate the percent of simulated secretions removed. Using a new ETT each time, a sample size of fourteen 10 French CleanSweep Closed Suction System devices and fourteen traditional closed suction catheter devices were tested following this procedure.

(difference in weight of the ETT before and after the cleaning procedure) Sample #

Removed simulated secretion weight [gr] *starting weight was 3 gr

% of Secretion removed

CleanSweep Closed Suction System

Traditional Closed Suction Catheter

CleanSweep Closed Suction System

Traditional Closed Suction Catheter

1

2.7

0.97

90%

32%

2

2.79

0.7

93%

23%

3

2.8

0.6

93%

20%

4

2.72

0.7

91%

23%

5

2.71

0.7

90%

23%

6

2.7

0.9

90%

30%

7

2.69

0.9

90%

30%

8

2.65

0.9

88%

30%

9

2.66

0.9

89%

30%

10

2.65

0.7

88%

23%

11

2.7

0.7

90%

23%

12

2.7

0.6

90%

20%

13

2.7

0.7

90%

23%

14

2.69

0.9

90%

30%

AVG

2.70

0.78

90%

26%

SD

± 0.04

± 0.13

1%

4%

Results: CleanSweep Closed Suction system removed an average of 2.70 gr of simulated secretions from a 3 gr starting weight (90% ± 1%), while the traditional closed suction catheter removed an average of 0.78 gr of simulated secretions from a 3 gr starting weight (26% ± 4%). Suction Removal Percentage: CleanSweep Closed Suction System vs. Traditional Closed Suction Catheter Percentage of Secretions Removed

1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 CleanSweep Closed Suction System

Traditional closed suction catheter

Individual standard deviations are used to calculate the intervals 95% CI of the mean

Conclusion: When compared to a traditional closed suction catheter the CleanSweep Closed Suction System removed 2.5 times more secretions, with 90% ± 1% of simulated secretions being removed with CleanSweep Closed Suction System as opposed to 26% ± 4% with a traditional closed suction catheter. This significant difference in secretion removal between the two closed suction catheters may be attributed to the dual operation of balloon sweeping and suction employed by of the new CleanSweep Closed Suction System. CleanSweep Closed Suction System’s enhanced in vitro secretion removal as compared to traditional closed suction catheters may help decrease mechanical airway resistance as a consequence of the increase in the internal radius of the ETT available for airflow.

References i Robert Wilkins, James, Stoller, Robert Macmarek. Eagn’s, Fundamentals of Respiratory Care. Ninth Edition. 2009. Pg. 695 ii Maggiore SM, Lellouche F, Pigeot J, Taille S, Deye N, Durrmeyer X, Richard JC, Mancebo J, Lemaire F, Brochard L. Prevention of endotracheal suctioning-induced alveolar derecruitment in acute lung injury. Am J Respir Crit Care Med. 2003 May 1;167(9):1215-24 iii Guglielminotti J, Desmonts J, Dureuil B. Effects of tracheal suctioning on respiratory resistances in mechanically ventilated patients. Chest 1998;113(5):1335-1338 iv Scott J, Dubosky M, Vines D, et al. Evaluation of Endotracheal Tube Scraping on Airway Resistance. Respiratory Care. 2017 Comparative bench test data may not be indicative of clinical performance. *Study sponsored by Biovo Technologies Ltd, which developed the technology for the CleanSweep ® Closed Suction System acquired by Teleflex in 2017. Study data interpreted by Dr. Stephen Luney, Medical Director Teleflex Medical Incorporated. Teleflex, the Teleflex logo, and CleanSweep are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2018 Teleflex Incorporated. All rights reserved. MC-004801

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