title: Reducing Accidental Dislodgement of the Percutaneous Endoscopic Gastrostomy: A Prospective Trial of the "SafetyBreak" Device.
abstract: BACKGROUND
  The percutaneous endoscopic gastrostomy (PEG) is a ubiquitous feeding tube with high rates of accidental dislodgement, with significant morbidity and health care costs. We hypothesized use of a decoupling device is a safe and effective mechanism to reduce dislodgements.
  
  
  METHODS
  We studied a prospective cohort of 100 patients from an academic center. Enrollment included patients requiring PEG tube placement with follow up extending through an individual's lifetime use of their PEG tube. The primary endpoint was accidental dislodgement of the principally placed PEG tube. The secondary endpoint was time to accidental dislodgement of the PEG tube.
  
  
  RESULTS
  All 100 patients received the SafetyBreak device and had complete follow-up. Half of the patients had at least a single episode of device decoupling, indicating prevention of dislodgement of the PEG. Eight patients ultimately had dislodgement, resulting in a significantly lower dislodgement rate when compared with a historical cohort (P = .036) and significantly longer survival of the PEG (log rank = 0.005). When compared with a concurrent cohort (without the device) there was also significantly lower dislodgement rate (P = .03) and a trend toward longer survival of the PEG (log rank = 0.08).
  
  
  CONCLUSIONS
  When compared with both a historical and concurrent cohort of patients, the SafetyBreak device reduces accidental dislodgement of PEG tubes. As an increasing number of PEGs are being placed, an increasing number of patients are at risk for dislodgement. The SafetyBreak device is an innovative, economical solution to the problem of accidental dislodgement of the PEG tube.
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA lhr2m@virginia.edu.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Rosenberger
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA.
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Guidry
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: Davis
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA.
authors.forename: Tjasa
authors.initials: T
authors.lastname: Hranjec
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA.
authors.forename: Vonda K
authors.initials: VK
authors.lastname: Johnston
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA.
authors.forename: Nolan A
authors.initials: NA
authors.lastname: Wages
authors.affiliation: Palmetto Health, Columbia, SC, USA.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Watson
authors.affiliation: University of Virginia Health System, Charlottesville, VA, USA.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Sawyer
mesh_terms: D000368:Aged; D001698:Biomedical Engineering / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data*; D015331:Cohort Studies; D004724:Endoscopy / Q000295:instrumentation*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005774:Gastrostomy / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011446:Prospective Studies
keywords: biomedical engineering; flexible endoscopy; gastric surgery; interventional endoscopy