1. A Fluid-Management Drape for Hysteroscopy: Innovation for Improved Patient Safety and Surgical Care.
- Author
-
Marshburn PB, Anderson-Montoya BL, Baek S, Zhao J, Franco CH, Deneault LM, Hansen-Lindner L, Matthews ML, Usadi RS, Coddington CC, Woolworth MB, and Hurst BS
- Subjects
- Adult, Computer Simulation, Female, Focus Groups, Humans, Patient Safety, Proof of Concept Study, Prospective Studies, User-Centered Design, Hysteroscopy instrumentation, Surgical Drapes
- Abstract
Background: Hysteroscopy requires accurate collection of unabsorbed distension media to measure patient fluid absorption. We assessed the effectiveness and usability of a novel total capture drape compared with a standard drape during hysteroscopy., Method: Simulation trials were followed by an early-phase study to compare fluid-capture efficiency and measures of drape usability during hysteroscopy randomizing the total capture drape compared with a standard drape., Experience: Simulation trials indicated complete collection of unabsorbed fluid with the total capture drape and progressive loss of unabsorbed fluid with the standard drape. An early-phase study with 68 women found no statistical difference between groups for the hysteroscopic fluid deficit, but saw fewer cases with lost fluid in the total capture drape compared with the standard drape. Direct observation and focus group data indicated a trend for better capture of unabsorbed fluid with the total capture drape, along with increased usability once surgeons became familiar with correct placement., Conclusion: Simulation and early-phase study results are favorable for the total capture drape, demonstrating comparable fluid collection with the standard drape. With repeated use and in-service training, surgeons expressed greater confidence in the accuracy of the hysteroscopic fluid deficit with the total capture drape compared with the standard drape. Design modifications should improve overall usability and fluid-capture efficiency., Competing Interests: Financial Disclosure Paul B. Marshburn, M.D. disclosed being the inventor of U.S. patent No. 10,182,877 granted on January 22, 2019, covering the Total Capture Drape design and use. He reported no funding or financial gain from the patented drape. Paul B. Marshburn disclosed a payment for consulting from Cardinal Health. Brittany L. Anderson-Montoya disclosed receiving funding from the Society for Simulation in Healthcare for Associate Editor duties for the Journal and Mission Health for a guest speaker lecture. Leslie Hansen-Lindner reports receiving funding for expert testimony. The other authors did not report any potential conflicts of interest., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF