Non-inferiority trial of a pedal controlled injection device: a step toward enhancing patient safety and operator independence during neural blockade
Received 23 February 2018
Accepted for publication 21 August 2018
Published 7 February 2019 Volume 2019:12 Pages 571—577
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Justinn Cochran
Peer reviewer comments 4
Editor who approved publication: Dr E Alfonso Romero-Sandoval
Syed Reefat Aziz,1 Daryl I Smith,2 Rose N Mbaye,1 Jacob T Gusman,1 Estefania I Garza,1 Bokai Wang,3 Changyong Feng,3 Nobuyuki-Hai Tran2
1Department of Biomedical Engineering, University of Rochester, School of Medicine and Dentistry, Rochester, NY, USA; 2Department of Anesthesiology, University of Rochester, School of Medicine and Dentistry, Rochester, NY, USA; 3Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY, USA
Background and objectives: Limitations in manpower in health care facilities, both in civilian and military settings, can severely affect patient safety as well as overall outcomes. Regional anesthesia via neural blockade is an effective means of managing uncontrolled acute pain, which has been associated with cardiopulmonary, endocrine, immunologic, and hematologic derangement in addition to the development of potentially life-threatening coagulopathy. We have designed a remote-controlled injection device that may expedite the performance of regional nerve blocks in these situations.
Methods: This work examines how the device affects the ability of the operator to act independently with respect to various block component times by statistically comparing device-assisted blockade with usual or clinically relevant techniques. The classic or two-person technique was compared with the foot-controlled technique.
Results: The results validated the hypothesis that the novel mechanism of performing a nerve block is not inferior to the classic technique with regard to the specified endpoints within our experimental design.
Conclusion: This confirmation indicates that the use of this device may be feasible when the use of another technique could be cumbersome, or otherwise untenable.
Keywords: regional anesthesia, neuromuscular blockade, medical device, non-inferiority trial, biomedical engineering
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