Feasibility and safety of a novel electromagnetic device for small-bore feeding tube placement

Abstract

BackgroundMisplacement of enteral feeding tubes (EFT) in the lungs is a serious and potentially fatal event. A recent Food and Drug Administration Patient Safety Alert emphasized the need for improved technology for the safe and effective delivery of EFTs.ObjectiveWe investigated the feasibility and safety of ENvue, a novel electromagnetic tracking system (EMTS) to aid qualified operators in the placement of EFT.MethodsThis is a prospective, single-arm study of patients in intensive care units at two US hospitals who required EFTs. The primary outcome was appropriate placement of EFTs without occurrence of guidance-related adverse events (AEs), as confirmed by both EMTS and radiography. Secondary outcomes were reconfirmation of the EFT tip location at a follow-up visit using the EMTS compared with radiography, tube retrograde migration from initial location and AEs.ResultsSixty-five patients were included in the intent-to-treat analysis. EFTs were successfully placed in 57 patients. In eight patients, placement was unsuccessful due to anatomic abnormalities. According to both the EMTS and radiography, no lung placements occurred. No pneumothoraces were reported, nor any guidance-related AEs. Precise agreement of tube tip location was achieved between the EMTS evaluations and radiographs for 56 of the 58 (96.5%) successful placements (one patient had two placements). Tube tip location was re-confirmed 12–49 hours after EFT insertion by the EMTS and radiographs in 48 patients (84%). For 43/48 patients (89.5%), full agreement between the EMTS and radiography evaluations was observed. For the five remaining patients, the misalignment between the evaluations was within the gastrointestinal tract. Retrograde migration from the initial location was observed in 4/49 patients (8%).ConclusionA novel electromagnetic system demonstrated feasibility and safety of real-time and follow-up tracking of EFT placement into the stomach and small intestine, as confirmed by radiographs. No inadvertent placements into the lungs were documented.Level of evidenceLevel V (large case series).

Challenges of de‐implementing feeding tube auscultation: A qualitative study

“…This is consistent with the literature on de-implementation; stopping a practice can be an independent function, or one practice may be substituted by another practice (Helfrich et al, 2018;Wang et al, 2018). Two EMPDs are approved for independent verification of feeding tubes (Jacobson et al, 2019;U.S. Food and Drug Administration [FDA], 2009).…”

“…This is consistent with the literature on de‐implementation; stopping a practice can be an independent function, or one practice may be substituted by another practice (Helfrich et al, 2018; Wang et al, 2018). Two EMPDs are approved for independent verification of feeding tubes (Jacobson et al, 2019; U.S. Food and Drug Administration [FDA], 2009). A recent study of clinical practice guidelines (CPGs) on feeding tube verification methods stated that evidence was lacking to endorse use of EMPDs, yet the CPGs were published 2015–2018 (Metheny et al, 2019), suggesting a need to update with recent evidence.…”

Complications of small-bore feeding tubes: is newer technology necessarily better?

“…Jacobson et al 1 keenly examined how a novel electromagnetic tracking system may be safely used to ensure correct placement of small-bore feeding tubes (SBFTs). Clinical practice has shifted such that SBFTs are preferred for short-term feeding due to a reduction in aspiration risk and perceived patient comfort.…”

“…Additional pulmonary complications include hemothoraces, pneumonias and broncho-pleural fistulas. 1 3 SBFTs employ a rigid guidewire—the suspected culprit behind direct pulmonary injury—for structural support. Their smaller caliber also increases risk of traversing an endotracheal tube cuff and passing into the distal bronchioles before detection.…”

“…The under-reported incidence of misplacement in the literature and the undetermined comparative cost of modern methods are of additional importance. 1 5 6 Thus, large-scale prospective studies establishing efficacy and cost-effectiveness of novel approaches against conventional practices are still necessary. Targeting populations at highest risk for misplacement—critically ill and neurologically injured patients—would also be of unique interest.…”