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

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).

Case of paradoxical embolic transient ischemic attack from an unusual extra cardiac shunt detected on a contrast-enhanced echocardiogram.

Paradoxical embolism due to extracardiac right to left shunts (RLSs) manifesting as stroke remains anecdotal. We describe a case of 63-year-old female who presented with a transient ischemic attack and at agitated saline contrast echocardiogram was found to have an unusual type of an extracardiac RLS. Further evaluation leads to diagnosis of superior vena cava (SVC) thrombosis from a prior indwelling central venous catheter. The SVC thrombosis induced systemic-pulmonary venous collaterals were responsible for this unusual extracardiac RLS and paradoxical transient ischemic attack. We discuss the diagnosis and management of this rare clinical case.

Questions of copyright.

The Berne Convention and the national laws on intellectual property fully apply to PRO instruments. The identification of and access to an original PRO instrument is often associated with copyright ownership. This is the copyright holder of the instrument who will control its access (distribution and reproduction), its adaptation or modification, and its translation. Copyright is a means to protect the integrity of an instrument. The ownership of an instrument should be defined in the beginning between all parties involved, and each step of the instrument's life, including distribution, should be anticipated for purpose of copyright.

Patient-reported outcome and quality of life instruments database (PROQOLID): frequently asked questions.

The exponential development of Patient-Reported Outcomes (PRO) measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database), the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet.PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at http://www.proqolid.org. The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.). The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually.Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration), dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database.