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Obstacles a principal investigator health professional may need to overcome in a pivotal investigational device exemption clinical trial of a Class 2 medical instrument at a major medical center / Lois Ramer, Raymond P. Briggs

データ種別 電子ブック
出版者 London : SAGE Publications Ltd
出版年 2017

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URL オンライン

EB5710742


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書誌ID OB00843282
本文言語 英語
一般注記 Includes bibliographical references and index
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There are major differences between large-scale clinical trials for medications and medical devices, especially low-risk medical devices (Class 2) intended primarily to improve hospital efficacy and patient comfort. Unlike the affirmative studies required for medications, and the step-by-step near-continuous evaluation of safety-critical medical instruments, Class 2 medical instruments often are given a pivotal investigational device exemption (IDE) clinical trial that demonstrates efficacy and comfort. One such medical device is the VeinViewer, which uses near-infrared illumination to help a nurse find a blood vessel. The simple question is, does the VeinViewer help measurably in a medical hospital setting? This study evaluated the effectiveness of the VeinViewer for peripheral vascular accessing in a pediatric hematology oncology clinic. After parental consent had been obtained, 53 patients were randomly assigned to either the VeinViewer group (n=27) or standard methods group (n=26). Data on number of attempts, procedural time, access complications, and patient and nurse satisfaction were collected. Patients randomized to the VeinViewer group required significantly less time to access a vein as compared with the standard methods group (p.05). The average age of participants was 13.1years (range: 1-21years) and was not significantly different between randomization groups (p=.789). Patients rated nurses as having significantly more skill than nurses who did not use VeinViewer (p.05) and assigned significantly higher scores for overall experience. Responses indicated by nurses using VeinViewer overall saw the device as clinically helpful
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著者標目 *Ramer, Lois
Briggs, Raymond P
統一書名標目 SAGE Research Methods. Cases. Part 2.
件 名 LCSH:Medical instruments and apparatus -- Evaluation  全ての件名で検索
LCSH:Clinical trials
分 類 LCC:R856
DC:610.28
巻冊次 ebook ; ISBN:9781526409881 ; PRICE:No price RefWorks出力(各巻)
資料種別 機械可読データファイル
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