ASPEN 2024 Poster

Marcia Belcher, MSN, BBA, RN, CCRN-CSC, CCNS

Robert Buckley, RN, CCM & Steve Heisa, RN

NeuroRestorative, Riverton, Utah, August 2021

Jesse C. James, CNSC, Williamson Medical Center, Franklin, TN 37067

1. Buckey, R. and Heisa, S. “The TubeClear Study: Clinical Study of Mechanical Enteral Tube Declogging.” Aug. 2021.
2. Blumenstein I, Shastri YM, Stein J. Gastroenteric tube feeding: techniques,problems and solutions. World J Gastroenterol. 2014;20:8505-8524.
3. Oley Foundation Member Survey: Enteral Feeding Tube Clogging and Resolution. In: Actuated Medical, Inc.; 2015.
4. Garrison, C. M., “Enteral Feeding Tube Clogging: What Are the Causes and What Are the Answers? A Bench Top Analysis.” Nutrition in Clinical Practice. 2018; 33(1):147-150.
5. Actuated Medical, Inc. Internal Test Report Doc. No. 1100791569-002.

BELLEFONTE, PA – Actuated Medical, Inc. (AMI) recently received its sixth Food and Drug Administration (FDA) 510(k) clearance for the TubeClear® system. Clearance number K200646 introduces a Clearing Stem model that is compatible with select gastro-jejunostomy (GJ) feeding tubes.

These complex dual lumen feeding tubes are often expensive and require surgery to place. When a clogged feeding tube of any type cannot be cleared, it requires replacement. The new TubeClear GJ-1422 Clearing Stem offers a mechanical option for clinicians to keep these expensive GJ tubes clear and avoid an unnecessary procedure to replace the tube. The GJ-1422 Clearing Stem is designed to work with MIC*, MIC-KEY* (Avanos Medical, Inc., Alpharetta, GA) and G-Jet® (Applied Medical Technology (AMT), Brecksville, OH) GJ feeding tubes that are 14-22 French diameter and have a jejunal length of 15-45 centimeters.

“Clogging in GJ tubes is one of the most common complaints we hear from clinicians and patients alike,” said AMI president and chief executive officer Maureen L. Mulvihill, PhD. “Being able to deliver a Clearing Stem that is compatible with our existing TubeClear system as well as GJ feeding tubes is an exciting opportunity for AMI to support vulnerable patients and improve their outcomes.”

The TubeClear system is an FDA cleared medical device that uses patented mechanical motion technology to maintain flow and clear clogs in most feeding and decompression tubes while the tube remains in the patient and works at bedside. Keeping these tubes clear prevents interruptions to feeding and medication delivery, allowing clinicians to maintain their focus on improving patient care and reducing healthcare cost associated with tube replacement. The system, which is comprised of reusable control boxes and single-use clearing stems, is designed, developed, and manufactured by AMI in Bellefonte, PA. The new GJ Clearing Stem is slated to be available for sale in clinical settings in early 2021.

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About Actuated Medical, Inc.

Actuated Medical develops medical devices that integrate electronically controlled motion technologies that improve patient outcomes and reduce healthcare costs. Their development process focuses on intellectual property, regulatory, and reimbursement strategies to decrease commercialization risk and attract medical device technology licensing partnerships. Their devices solve unmet clinical needs in target markets (e.g., GI, oncology, critical care and pediatrics). Actuated Medical a certified women-owned business located in Bellefonte, PA and is ISO 13485:2016 certified.

For more information, please visit http://www.actuatedmedical.com

No one wants a clogged feeding tube.  They impact the patient’s ability to receive adequate nutrition and keep medication on schedule.[1]  If the clog cannot be cleared, the tube is replaced. Tube replacement can be a painful, risky, and costly procedure that can include x-rays, surgery, and emergency transportation.  Plus, it takes hours or even days before the patient receives a new tube. The lack of medication, nutrition, and hydration increases the patient’s cost of care.

Because of this, nurses and caregivers have tried several different strategies for clearing and preventing clogs.  From flushing with soda to using products designed for clogged feeding tubes, below are some of the most common solutions.

Water

The current standard practice, health care facilities and feeding tube manufacturers alike recommend flushing tubes with water regularly to treat and prevent clogs.  In spite of this, clogs still occur as often as 15% of the time.[2] An internal bench study at Actuated Medical, Inc. showed feeding formula still left on the interior tube walls after flushing with water.[4] Power flushing, a technique in which the syringe depressed with extra force, may cause the water to come back out of the entry port, or worse – rupture the tube.[2,3]

When clogged, water flushing restored feeding tube flow just 20% of the time and took nearly two hours.[5]

Soft Drinks

Enzyme Mixtures

Another common solution involves crushing enzymes and mixing with baking soda to dissolve the clog.  Early studies showed this to be effective.[2] However, the compound used in these studies was discontinued when the Food and Drug Administration (FDA) started regulating enzymes.[2] Some alternatives have enteric coating, making it difficult to crush and more likely to create clogs.  Other enzymes tested for removing clogs were less than 50% effective.[10]

Enzyme-Based Clog Removing Products

While a clogged feeding tube is a common problem, few products have been developed to treat them.  One such product, Clog Zapper (Avanos Medical, Inc., Alpharetta, GA), is a pre-mixed food-based enzyme that includes a stylet for improved access to the clog.  A recent bench study found limited effectiveness against clogs at just 33%. It also takes a long time – in the same study, Clog Zapper required two hours or more to work (if it did at all).[5] The product is designed for formula clogs and is ineffective in clogs containing medication.  In addition, Clog Zapper’s label states that it Contains Tree Nuts (Coconuts).  Therefore, clinicians must ensure that their patients do not have a food allergy to Coconuts prior to use.

Manual Clog Removing Devices

When fluids and enzymes don’t work, clinicians turn to mechanical tools designed for clogged feeding tubes. One advantage of these types of devices: the clog contents don’t matter.

Declogger (Bionix Development Corporation, Toledo, OH) is a plastic screw-like device for large-diameter feeding tubes. There is limited information available about its effectiveness. A few adverse events have been reported in which the tip of the device broke off inside the feeding tube.

Powered Clog Clearing Devices

The downside? Limited published clinical data and minimal reimbursement. But that’s a defining characteristic of innovation; early adopters are beginning to see its benefits to patient care and nursing experience.

What are your experiences with clogged feeding tubes?  Have you used any of the solutions mentioned in this article, or perhaps something entirely different?

References:

1. Bourgault AM, Heyland DK, Drover JW, Keefe L, Newman P, Day AG. Prophylactic pancreatic enzymes to reduce feeding tube occlusions. Nutr Clin Pract. 2003;18(5):398-401.
2. Dandeles LM, Lodolce AE. Efficacy of agents to prevent and treat enteral feeding tube clogs. Ann Pharmacother. 2011;45(5):676-680.
3. Fisher C, Blalock B. Clogged Feeding Tubes: A Clinician’s Thorn. Practical Gastroenterology. 2014:16-22.
4. Hayes KD, Hayes DD. Best practices for unclogging feeding tubes in adults. Nursing2019. 2018;48:1.
5. Garrison CM. Enteral Feeding Tube Clogging: What Are the Causes and What Are the Answers? A Bench Top Analysis. Nutr Clin Pract. 2018;33(1):147-150.
6. Boullata JI, Carrera AL, Harvey L, et al. ASPEN Safe Practices for Enteral Nutrition Therapy. JPEN J Parenter Enteral Nutr. 2017;41(1):15-103.
7. Rucart PA, Boyer-Grand A, Sautou-Miranda V, Bouteloup C, Chopineau J. Influence of unclogging agents on the surface state of enteral feeding tubes. JPEN J Parenter Enteral Nutr. 2011;35(2):255-263.
8. Metheny N, Eisenberg P, McSweeney M. Effect of feeding tube properties and three irrigants on clogging rates. Nurs Res. 1988;37(3):165-169.
9. Zoeller, S., Bechtold, M.L., Burns, B., Cattell, T., Grenda, B., Haffke, L., Larimer, C., Powers, J., Reuning, F., Tweel, L., Guenter, P. Dispelling Myths and Unfounded Practices About Enteral Nutrition. Nutrition in Clinical Practice. 2020. 1-9.
10. Stumpf JL, Kurian RM, Vuong J, Dang K, Kraft MD. Efficacy of a Creon delayed-release pancreatic enzyme protocol for clearing occluded enteral feeding tubes. Ann Pharmacother. 2014;48(4):483-487.
11. TubeClear | Occlusion Clearing System. Actuated Medical Inc. https://tubeclear.com/. Published 2012. Accessed.
12. Belcher, M. “An Active Device for Restoring Patency in Clogged Small Bore Feeding and Decompression Tubes, Case Report Series.” 2016. https://tubeclear.com/white-paper-download.

Enteral nutrition (EN) is provided for patients that have a functioning lower gastrointestinal (GI) tract but are unable to orally ingest nutrients and medication and are at risk for malnutrition.[1] Feeding tubes (Tubes) provide these patients essential nutrition, life-sustaining medications and hydration. Numerous conditions may necessitate long-term EN, including GI dysfunction, cancer, cystic fibrosis, neurological disorders, burn patients, congenital heart disease, Alzheimer’s disease, Parkinson’s disease, and congenital metabolic abnormalities.[1,2] Maintaining Tube patency is critical for many, as EN interruptions are often associated with poor clinical outcomes. Tube clogging (see Figure 1) is the most frequently reported mechanical complication associated with feeding tubes, with reported clogging rates ranging from 9-35%.[3-5]  A recent survey of Oley Foundation members (180+ patients with feeding tubes and/or caretakers) indicated that up to 81% of non-acute Tubes become clogged, with 39.4% requiring a tube replacement due to clogs.[6]  Clogs result in the interruption of patient’s nutrition and medication regimens, representing a burden to both caregivers and patients.

Figure 1: Images of actual clogged feeding tubes submitted by three (3) different hospitals to Actuated Medical, Inc.

Common approaches to maintain Tube patency include regular flushing with water, carbonated sodas, and enzymatic solutions immediately after administering nutrition or medication. Some healthcare facilities add procedures for adequately crushing medications to prevent clogs. Current methods for unclogging Tubes are time-consuming and unreliable, often ending in patients having to undergo Tube replacements. Tube replacements are associated with their own set of risks, including the need for patient transport to the hospital, transfer to interventional radiology (IR) for radiological guidance or Tube placement confirmation following placement, exposing patients to radiation exposure, or surgical interventions which can expose patients to anesthesia.[7-10] Moreover, Tube misplacements into the bronchial tree reportedly occur in 2.4-3.2% of all nasogastric (NG) tube insertions,[11] a serious complication which, if unidentified, results in pneumonitis, pneumonia, and/or pneumothorax.[11]

Actuated Medical, Inc. (AMI) aimed to directly compare the prophylactic use of the TubeClear system, an actuated mechanical clearing device, to standard practice water flushes at reducing inner wall Tube material buildup, as a means of reducing subsequent material adherence and Tube clogging in vitro. Establishing protocols that could minimize clog formation would be invaluable for maintaining Tube patency and allowing for nutrition and medication regimens to remain uninterrupted.

Methods

Figure 2: Tube in GI model being pumped with formula.

Figure 3: Percent change in mass of NG tubes flushed with with either water alone (Gray Bar) or in conjunction of the TubeClear system (Orange Bar) to  remove buildup residue within Tube inner walls. N=22, 11/treatment; Unpaired T-test for significance, Bars= standard error  of the mean. *p <0.0001.

Results

The TubeClear system in conjunction with water flushes removed 77.1±2.4% of mass while Water flushing alone added 68.5±15.8% (see Figure 3, unpaired T-test p<0.0001).[12]  As added water was removed by post-clearing drying, the added mass, in Water group, was likely formula sticking to the pre-existing Tube material buildup. Images of the partially clogged feeding tubes treated with water or combined with the TubeClear system demonstrated visual differences (see Figure 4), confirmed with mass measurements.

• All Tubes cleared by TubeClear decreased in mass, while nearly all the Tubes flushed with water alone, increased in mass.
• The TubeClear system was 145.6% more effective than water alone at removing buildup.

Figure 4: Representative examples of partially clogged feeding tubes treated with water alone (top) or in conjunction with the TubeClear system (Bottom) to  remove buildup residue within Tube inner walls.

Conclusions

This work demonstrates that compared to water flushes alone, proactive use of the TubeClear system prior to Tube occlusions can minimize added material buildup from adhering to Tube inner walls, maintaining full Tube diameter and reducing the risk of future clogging, enabling uninterrupted and optimal EN delivery.

References:

1. Ireton-Jones C, DeLegge M. Handbook of Home Nutrition Support. Sudburry, MA: Jones and Bartlett; 2007.
2. Pederson A. Enteral Feeding (Tube Feeding). Gaining and Growing: Assuring Nutritional Care of Preterm Infants. http://depts.washington.edu/growing/Nourish/Tubes.htm. Accessed2000.
3. Marcuard SP, Stegall KS. Unclogging feeding tubes with pancreatic enzyme. JPEN J Parenter Enteral Nutr. 1990;14(2):198-200.
4. Bourgault AM, Heyland DK, Drover JW, Keefe L, Newman P, Day AG. Prophylactic pancreatic enzymes to reduce feeding tube occlusions. Nutr Clin Pract. 2003;18(5):398-401.
5. Shiram K, Jayanth, V., Lakshmi, R., George, V. Prophylactic Locking of Enteral Feeding Tubes With Pancreatic Enzymes. Journal of Parenteral and Enteral Nutrition. 2012;21(6):353-356.
6. Oley Foundation Member Survey:  Enteral Feeding Tube Clogging and Resolution. In: Actuated Medical, Inc.; 2015.
7. Mathus-Vliegen L, Koning H. Percutaneous endoscopic gastrostomy and gastrojejunostomy: a critical reappraisal of patient selection, tube function and the feasibility of nutritional support during extended follow-up. Gastrointest Endosc. 1999;50(6):746-754.
8. Sy K, Dipchand A, Atenafu E, et al. Safety and effectiveness of radiologic percutaneous gastrostomy and gastro jejunostomy in children with cardiac disease. AJR Am J Roentgenol. 2008;191(4):1169-1174.
9. Towbin R, Ball WJ, Bissett Gr. Percutaneous gastrostomy and percutaneous gastrojejunostomy in children: antegrade approach. Radiology. 1988;168(2):473-476.
10. Smith R-M, Myers S. 2 devices that unclog feeding tubes. RNWeb. http://rn.modernmedicine.com/rnweb/article/articleDetail.jsp?id=142656#intro. Published 2005. Accessed March 9, 2010.
11. Stayner JL, Bhatnagar A, McGinn AN, Fang JC. Feeding tube placement: errors and complications. Nutr Clin Pract. 2012;27(6):738-748.
12. Actuated Medical Inc. TubeClear Prophylactic Test Report: 1100791569, Rev002. 2019.