Cortrak-assisted feeding tube insertion: A comprehensive review of adverse events in the maude database

Annette Bourgault, Lillian Aguirre, Joseph Ibrahim

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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 CORTRAKassisted 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.

Original languageEnglish (US)
Pages (from-to)149-156
Number of pages8
JournalAmerican Journal of Critical Care
Volume26
Issue number2
DOIs
StatePublished - Mar 1 2017

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Enteral Nutrition
Databases
Lung
Equipment and Supplies
Pneumothorax
Electromagnetic Phenomena
United States Food and Drug Administration
Radiography
Small Intestine
Pneumonia
Stomach
Research Personnel
Wounds and Injuries

ASJC Scopus subject areas

  • Critical Care

Cite this

Cortrak-assisted feeding tube insertion : A comprehensive review of adverse events in the maude database. / Bourgault, Annette; Aguirre, Lillian; Ibrahim, Joseph.

In: American Journal of Critical Care, Vol. 26, No. 2, 01.03.2017, p. 149-156.

Research output: Contribution to journalArticle

Bourgault, Annette ; Aguirre, Lillian ; Ibrahim, Joseph. / Cortrak-assisted feeding tube insertion : A comprehensive review of adverse events in the maude database. In: American Journal of Critical Care. 2017 ; Vol. 26, No. 2. pp. 149-156.
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abstract = "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 CORTRAKassisted 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.",
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N2 - 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 CORTRAKassisted 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.

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