Pneumothoraces Prevented With Use of Electromagnetic Device to Place Feeding Tubes

Annette M. Bourgault, PhD, RN, CNL; Jan Powers, PhD, RN, CCNS, CCRN, NE-BC; Lillian Aguirre, DNP, APRN, CCNS, CCRN

Disclosures

Am J Crit Care. 2020;29(1):22-32. 

In This Article

Abstract and Introduction

Abstract

Background: A US Food and Drug Administration safety letter warned about the risk for pneumothoraces during feeding tube insertion despite the use of electromagnetic placement devices that provide real-time visualization of feeding tube position.

Objectives: To systematically assess pulmonary placement and pneumothoraces in CORTRAK-assisted feeding tube insertions.

Methods: CINAHL, MEDLINE, and Cochrane databases were searched for studies of CORTRAK-assisted feeding tube insertion. Thirty-two studies documenting pulmonary placement and/or complications of feeding tube insertion were found.

Results: Operators recognized pulmonary placement on insertion tracings during 202 CORTRAK-assisted feeding tube insertion procedures, resulting in the immediate withdrawal of 199 feeding tubes. One pneumothorax was identified later by radiography. Seven pulmonary placements were not recognized by CORTRAK operators at the time of feeding tube insertion, resulting in 2 pneumothoraces. The incidence of pneumothorax for CORTRAK-assisted feeding tube insertions was 0.02% (3 of 17 039). Of the feeding tubes inserted into the pulmonary system—either found during or after the procedure—1.4% (3 of 209) resulted in pneumothoraces (as opposed to the 19% to 28% incidence of pneumothorax for blind feeding tube insertions. Operators recognizing pulmonary placement on CORTRAK insertion tracings may have prevented 97% (202 of 209) of feeding tubes from being inserted farther into the respiratory tract.

Conclusions: Feeding tube insertion with an electromagnetic placement device is advantageous over blind feeding tube insertion because the operator can recognize pulmonary placement early and withdraw the feeding tube, thus decreasing the risk of pulmonary complications.

Introduction

The US Food and Drug Administration (FDA) issued a safety alert letter in April 2018 to warn health care providers about the occurrence of pneumothoraces leading to injury or death following feeding tube (FT) insertion, despite the use of an enteral access system such as CORTRAK (Avanos Medical).[1] The FDA reported on 51 pneumothorax events during a 5-year period, the majority of which required immediate medical intervention to avoid further clinical deterioration.[1] The FDA letter did not distinguish between pulmonary FT placement that was recognized by the electromagnetic placement device (EMPD) operator at the time of FT insertion and that which went unrecognized by the operator.[1]

CORTRAK, an EMPD, received FDA approval in 2009 for independent confirmation of FT placement.[2] With the patient supine or positioned according to institutional protocol, a receiver unit is positioned midline on the patient's abdomen with the upper foot of the receiver unit over the xiphoid process and parallel to the spine.[3,4] An electromagnetic signal from a sensor located in the distal end of the FT stylet is converted to an insertion tracing on the portable CORTRAK monitor.[4] This tracing allows the operator to visualize the distal end of the FT in relation to an x-y axis, although no anatomical structures are visible. Three insertion views are available for interpretation by the operator: (1) anterior, (2) depth cross-sectional, and (3) lateral. Insertion tracings can be printed, and a predetermined number are saved to the EMPD monitor for future review as needed.[4]

These real-time tracings illustrating the FT insertion pathway are the primary benefit of CORTRAK-assisted FT insertion. Experienced operators can quickly recognize pulmonary placement on the insertion tracing when a FT deviates sharply from midline above the horizontal axis in the anterior view[4] (Figure 1). In other insertion views (lateral and depth cross-sectional), pulmonary FT placement will appear closer to the anterior chest wall than gastrointestinal placement. FTs may be immediately withdrawn before entering the distal respiratory tract, reducing risk for patient harm.[5,6]

Figure 1.

CORTRAK insertion tracings (anterior view) show postpyloric (A), right pulmonary (B), and left pulmonary (C) placement of feeding tube.
Reprinted with permission from Avanos.

Although several studies have documented positive outcomes from CORTRAK-assisted FT insertion,[7–10] others have highlighted the need for a highly trained operator.[6,11–14] Positive outcomes have included high correlation of FT location between the CORTRAK and radiographic imaging, fewer FT insertions in the lungs because of early recognition of pulmonary placement, and decreased delay to onset of feeding.[9,15] Some institutions no longer perform confirmatory radiography and use CORTRAK as their primary source of FT confirmation.[16] Two independent reviews of CORTRAK-related adverse events in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database showed that negative outcomes resulting in injury or death were associated with operator error, often owing to failure of the operator to accurately interpret the insertion tracing.[11–13]

Real-time insertion tracing provided by electromagnetic device allows operators to visually track feeding tube pathway throughout the insertion process.

The purpose of this integrative review was to assess reports of FT deviation into the pulmonary system during use of the CORTRAK EMPD. We did not differentiate between CORTRAK models; CORTRAK 2 EAS is included within the broader term CORTRAK. Feeding tube deviation into the pulmonary system was defined as any of the following 3 cases: (1) pulmonary placement recognized immediately and followed by immediate FT removal, (2) pulmonary placement suspected but FT removal delayed until position could be verified by another method such as radiography, and (3) pulmonary placement not recognized and FT removal delayed until position was verified by another method. Pulmonary FT placement is the complication of greatest concern as described in the FDA letter and is the focus of this review; other complications related to FT insertion are not addressed in this article.

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