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).