Clinical Data Clinical Data

FEASIBILITY AND SAFETY OF A NOVEL ELECTROMAGNETIC DEVICE FOR SMALL-BORE FEEDING TUBE PLACEMENT

BACKGROUND:

Enteral nutrition is the preferred route for the provision of nutritional support in most critically ill patients. Misplacement of Eteral Feeding Tubes (EFT) in the lungs is a serious and potentially fatal event. A recent FDA Patient Safety Alert emphasized the need for an improved technology for safe and effective delivery of EFTs.

OBJECTIVE:

To investigate the feasibility and safety of ENvue™, a novel ElectroMagnetic Tracking System (EMTS) designed by ENvizion, to aid qualified operators in the placement of EFT.

METHODS:

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, as confirmed by both the EMTS and radiography. Secondary outcome was reconfirmation of the tube tip location at a follow-up visit using the EMTS compared to radiography.

RESULTS:

Sixty-five (65) patients were included in the intent-to-treat analysis and underwent a tube placement attempt. EFTs were successfully placed in 57 patients. In 8 patients, placement was unsuccessful due to anatomic abnormalities such diaphragmatic hernia or obstruction. According to both the electromagnetic tracking system and radiography, no lung placements occurred in any of the EFTs placed. No pneumothoraces were reported, nor any guidance-related adverse events.

envizion Postprocedural radiograph [A] with comparison to EMTS screen [B]

Precise agreement of tube tip location was achieved between the electromagnetic tracking system evaluations and radiographs for 56 of the 58 (96.5%) successful placements, see Table 1 (one patient had two placements). In the other two placements, the electromagnetic tracking system showed the tip of the EFT in the stomach and the subsequent radiograph showed it to be post-pyloric.

Table 1: Comparison between post-procedure EMTS tip location immediately after placement and radiograph tip location within 5 hours of placement
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* Shaded values represent complete agreement between tip location according to the EMTS and radiography

Tube tip location was re-confirmed 12-49 hours after EFT insertion by the EMTS and radiographs in 48 (84%) patients. For 43/48 (89.5%) patients, full agreement between the EMTS and radiography evaluations was observed, see Table 2. For the 5 remaining patients, the misalignment between the evaluations was within the gastrointestinal tract.

Table 2: Comparison between EMTS tip location and radiograph tip location at the follow-up visit (12-49 hours after placement of the feeding tube)
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CONCLUSION:

A 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.