Funding for this research was provided by:
National Institute of Neurological Disorders and Stroke (NS045488)
Article History
Received: 16 September 2016
Accepted: 23 March 2017
First Online: 3 April 2017
Compliance with ethical standards
:
: Paul Benni is an employee and owns stock in CAS Medical Systems, Inc., the manufacturer of the FORE-SIGHT Elite NIRS monitor. Paul Benni is an inventor named on several patents relating to NIRS, but has no individual royalty rights (CAS Medical Systems own rights). David MacLeod received compensation for his work on this study through Duke University. Keita Ikeda received compensation for his work on this study through Duke University. Hung-Mo Lin received consultancy fee for statistical analysis.
: All procedures performed in studies involving human participants were approved by The Duke University Health System Institutional Review Board for Clinical Investigations (DUHS IRB). DUHS IRB complies with all U.S. regulatory requirements related to the protection of human research participants. Specifically, the DUHS IRB complies with 45CFR46, 21CFR50, 21CFR56, 21CFR312, 21CFR812, and 45CFR164.508-514. In addition, the DUHS IRB complies with the Guidelines of the International Conference on Harmonization to the extent required by the U. S. Food and Drug Administration.
: Informed written consent was obtained from all study subjects.