PMID- 31799414
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220411
IS  - 2397-5776 (Electronic)
IS  - 2397-5776 (Linking)
VI  - 4
IP  - 1
DP  - 2019
TI  - Feasibility and safety of a novel electromagnetic device for small-bore feeding 
      tube placement.
PG  - e000330
LID - 10.1136/tsaco-2019-000330 [doi]
LID - e000330
AB  - BACKGROUND: Misplacement 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. OBJECTIVE: We investigated the feasibility and safety of ENvue, 
      a novel electromagnetic tracking system (EMTS) to aid qualified operators in the 
      placement of EFT. METHODS: This 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. RESULTS: Sixty-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%). 
      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. LEVEL OF EVIDENCE: Level V (large case series).
CI  - (c) Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Jacobson, Lewis E
AU  - Jacobson LE
AD  - Trauma Department, St. Vincent Indianapolis Hospital, Indianapolis, Indiana, USA.
FAU - Olayan, May
AU  - Olayan M
AD  - Center for Human Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Williams, Jamie M
AU  - Williams JM
AD  - Trauma Department, St. Vincent Indianapolis Hospital, Indianapolis, Indiana, USA.
FAU - Schultz, Jacqueline F
AU  - Schultz JF
AD  - Trauma Department, St. Vincent Indianapolis Hospital, Indianapolis, Indiana, USA.
FAU - Wise, Hannah M
AU  - Wise HM
AD  - Trauma Department, St. Vincent Indianapolis Hospital, Indianapolis, Indiana, USA.
FAU - Singh, Amandeep
AU  - Singh A
AD  - Center for Human Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Saxe, Jonathan M
AU  - Saxe JM
AD  - Trauma Department, St. Vincent Indianapolis Hospital, Indianapolis, Indiana, USA.
FAU - Benjamin, Richard
AU  - Benjamin R
AD  - Center for Human Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Emery, Marie
AU  - Emery M
AD  - Center for Human Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Vilem, Hilary
AU  - Vilem H
AD  - Center for Human Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Kirby, Donald F
AU  - Kirby DF
AD  - Center for Human Nutrition, Cleveland Clinic, Cleveland, Ohio, USA.
LA  - eng
PT  - Journal Article
DEP - 20191113
PL  - England
TA  - Trauma Surg Acute Care Open
JT  - Trauma surgery & acute care open
JID - 101698646
PMC - PMC6861064
COIS- Competing interests: None declared.
EDAT- 2019/12/05 06:00
MHDA- 2019/12/05 06:01
PMCR- 2019/11/13
CRDT- 2019/12/05 06:00
PHST- 2019/05/03 00:00 [received]
PHST- 2019/09/23 00:00 [revised]
PHST- 2019/10/09 00:00 [accepted]
PHST- 2019/12/05 06:00 [entrez]
PHST- 2019/12/05 06:00 [pubmed]
PHST- 2019/12/05 06:01 [medline]
PHST- 2019/11/13 00:00 [pmc-release]
AID - tsaco-2019-000330 [pii]
AID - 10.1136/tsaco-2019-000330 [doi]
PST - epublish
SO  - Trauma Surg Acute Care Open. 2019 Nov 13;4(1):e000330. doi: 
      10.1136/tsaco-2019-000330. eCollection 2019.