Cortrak-Assisted Feeding Tube Insertion: A Comprehensive Review of Adverse Events in the MAUDE Database

2017 ◽  
Vol 26 (2) ◽  
pp. 149-156 ◽  
Author(s):  
Annette M. Bourgault ◽  
Lillian Aguirre ◽  
Joseph Ibrahim

Background Electromagnetic devices to guide feeding tube placement such as the CORTRAK Enteral Access System have shown promising results; however, researchers in recent studies have expressed concern that a higher level of user expertise may be required for safe use. Objectives To review adverse events related to CORTRAK-assisted feeding tube insertion reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database. Methods A retrospective, secondary analysis of the MAUDE database was performed to evaluate adverse events (ie, injury or death of patient) related to CORTRAK. Results Fifty-four adverse events between January 1, 2006 and February 29, 2016 were identified and reviewed. Most events (98%) involved feeding tube placement in the lungs (37%, left lung; 46%, right lung; 15%, not specified). Lung complications included pneumothorax (77%) and pneumonitis (21%). Death occurred in 17% of lung placements. Clinicians failed to recognize placement in 89% of CORTRAK insertion tracings reviewed. Conclusions Lung placement is not unique to CORTRAK and is an inherent risk of all feeding tube insertions. In known or suspected lung placement, feeding tubes should be removed and radiography performed to assess for pneumothorax. Clinicians must observe closely for lung placement and discriminate lung from gastric placement on insertion tracings. Clinicians require specialized training and experience to develop competency in using the CORTRAK device, although the exact amount of experience needed is unknown.

2017 ◽  
Vol 26 (2) ◽  
pp. 157-161 ◽  
Author(s):  
Norma A. Metheny ◽  
Kathleen L. Meert

Background Radiography is the accepted gold standard for testing feeding tube placement; however, an electromagnetic tube-placement device (ETPD) is sometimes used in lieu of radiography for this purpose. High success rates have been reported when the device was used by well-trained individuals. However, authors previously described 20 cases that occurred between 2007 and 2012 in which clinicians voluntarily reported inability to detect inadvertent tube insertions in the respiratory tract while using an ETPD. Objective To describe case reports to the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database between 2013 and 2015 regarding inadvertent respiratory placement of feeding tubes by operators using an ETPD. Methods The MAUDE database was searched for cases dated from January 1, 2013, through December 31, 2015, along with selected brand names. A total of 34 cases (25 after removal of duplicates) were located in which a feeding tube was inserted into the respiratory tract during insertions assisted by an ETPD. Results Sites of the malpositioned tubes included the right lung (n = 13), left lung (n = 6), unspecified lung (n = 4), and bronchus (n = 2). A pneumothorax occurred in 17 of the 25 misplacements; feedings were administered in 6 cases. Conclusions Many case reports involved clinicians failing to recognize tube misplacements in the respiratory tract while using an ETPD. These reports provide evidence that not all clinicians can use the device effectively to detect malpositioned tubes. Thus, one must continue to question the wisdom of eliminating radiographic confirmation of tube position before starting feedings.


2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Qing-Jun Jiang ◽  
Cai-Feng Jiang ◽  
Qi-Tong Chen ◽  
Jian Shi ◽  
Bin Shi

Background. Critically ill patients can benefit from enteral nutrition with postpyloric feeding tubes, but the low success rate limits its wide use. Erythromycin could elevate the success rate of tube insertion, but its clinical efficiency still remains controversial. Methods. Included studies must be RCTs which assessed the success rate of postpyloric feeding tube insertion using erythromycin. Results. 284 patients were enrolled in six studies. Meta-analysis showed that erythromycin significantly increases the rate of successful postpyloric feeding tube placement (RR 1.45, 95% CI (1.12, 1.86)) and did not increase the risk of adverse effects (RR 2.15, 95% CI (0.20, 22.82)). Subgroup analysis showed that unweighted feeding tubes (RR 1.47, 95% CI (1.03, 2.11)) could significantly increase the success rate. Country of study, intravenous route of erythromycin, and year of participant enrollment did not influence these results. Conclusions. Erythromycin significantly increases the success rate of postpyloric feeding tube placement. This suggests that erythromycin can be used as an auxiliary method to improve the success rate of bedside insertion.


Author(s):  
T Benstead ◽  
C Jackson-Tarlton ◽  
D Leddin

Background: Dysphagia from ALS may be treated by enteral nutrition; however criteria for timing of feeding tube placement has not been well studied. The aim of this project was to better understand the practice of enteral nutrition management within Canadian ALS clinics. Methods: ALS clinics were asked if they had written guidelines for timing of PEG insertion and if not, what criteria they use to make this decision. Results: Responses from 10 of 17 clinics were received. One clinic had written guidelines. Most used decline in respiratory function, dysphagia, weight loss or some combination of all three. Six clinics reported dropping FVC, ranging from 70% to 50% as prompting tube insertion. Five clinics reported weight loss as part of their criteria. Dysphagia was reported as the most important factor by 7 clinics. Psychological readiness for tube placement was a key factor in 3 clinics. Some clinics comment they place tubes in advance of dysphagia. Conclusion: Criteria for tube insertion varies between clinics. Practices generally reflect published recommendations, but vary on the emphasis of specific criteria. The lack of strong scientific evidence to guide decisions may contribute to management variability. Further study is needed to guide practice.


2021 ◽  
Vol 9 ◽  
Author(s):  
Sirima Ketsuwan ◽  
Pornthep Tanpowpong ◽  
Nichanan Ruangwattanapaisarn ◽  
Supatra Phaopant ◽  
Nattanicha Suppalarkbunlue ◽  
...  

Objective: Impaired gastric emptying is a common cause of delayed feeding in critically ill children. Post-pyloric feeding may help improve feeding intolerance and nutritional status and, hence, contribute to a better outcome. However, post-pyloric feeding tube insertion is usually delayed due to a technical difficulty. Therefore, prokinetic agents have been used to facilitate blind bedside post-pyloric feeding tube insertion. Metoclopramide is a potent prokinetic agent that has also been used to improve motility in adults and children admitted to intensive care units. The objective of this study was to determine the efficacy of intravenous metoclopramide in promoting the success rate of blind bedside post-pyloric feeding tube placement in critically ill children.Design: The design of this study is randomized, double blind, placebo controlled.Setting: The setting of the study is a single-center pediatric intensive care unit.Patients: Children aged 1 month−18 years admitted to the pediatric intensive care unit with severe illness or feeding intolerance were enrolled in this study.Intervention: Patients were randomly selected to receive intravenous metoclopramide or 0.9% normal saline solution (the placebo) prior to the tube insertion. The study outcome was the success rate of post-pyloric feeding tube placement confirmed by an abdominal radiography 6–8 h after the insertion.Measurements and Main Results: We found that patients receiving metoclopramide had a higher success rate (37/42, 88%) of post-pyloric feeding tube placement than the placebo (28/40, 70%) (p = 0.04). Patients who received sedative drug or narcotic agent showed a tendency of higher success rate (p = 0.08).Conclusion: Intravenous metoclopramide improves the success rate of blind bedside post-pyloric placement of feeding tube in critically ill children.Trial Registration: Thai Clinical Trial Registry TCTR20190821002. Registered 15th August 2019.


2020 ◽  
Vol 29 (21) ◽  
pp. 1277-1281
Author(s):  
Stephen Taylor ◽  
Alex Manara ◽  
Jules Brown ◽  
Kaylee Sayer ◽  
Rowan Clemente ◽  
...  

Electromagnetic (EM) guided enteral tube placement may reduce lung misplacement to almost zero in expert centres, but more than 60 undetected misplacements had occurred by 2016 resulting in major morbidity or death. Aim: Determine the accuracy of manufacturer guidance in trace interpretation against what is referred to as the ‘GI flexure system’. Methods: The authors prospectively observed the accuracy of the ‘GI flexure system’ of trace interpretation against manufacturer guidance in primary nasointestinal (NI) tube placements. Findings: Contrary to manufacturer guidance, 33% of traces deviated >5 cm from the sagittal midline and 26.5% were oesophageal when entering the lower left quadrant, incorrectly indicating lung and gastric placement, respectively. Conversely, the GI flexure system identified ≥99.4% of GI traces when they reached the gastric body flexure; 100% at the superior duodenal flexure. All lung misplacements were identified by the absence of GI flexures. Conclusion: Current manufacturer guidance should be updated to the GI flexure system of interpretation.


HPB ◽  
2017 ◽  
Vol 19 ◽  
pp. S149
Author(s):  
R. Kirks ◽  
P. Lorimer ◽  
Y.E. Warren ◽  
A. Cochran ◽  
M. Fruscione ◽  
...  

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