Evans, Douglas
Shure, Deborah
Clark, Linda
Criner, Gerard J.
Dres, Martin
de Abreu, Marcelo Gama
Laghi, Franco
McDonagh, David
Petrof, Basil
Nelson, Teresa
Similowski, Thomas http://orcid.org/0000-0003-2868-9279
Funding for this research was provided by:
Lungpacer Inc
Article History
Received: 25 September 2018
Accepted: 31 December 2018
First Online: 17 January 2019
Ethics approval and consent to participate
: The RESCUE 2 study has been ethically approved by competent institutional bodies in the two participating countries. In France, a global authorization relevant for all study sites has been granted by the Comité de Protection des Personnes Sud-Est VI, Clermont-Ferrand, France (decision # dated November 9, 2017) and by the competent authority (Agence Nationale de Sécurité du Médicament et des produits de santé) on June 32,017. In Germany, the study has been approved by the central Ethics Committee RWTH Aachen (August 14, 2017), which is relevant for each participating center and the competent authority (Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM) on September 1, 2017. Written informed consent will be obtained from all patients participating in the study, as a mandatory prerequisite to inclusion.
: Not applicable.
: DE reports personal fees from Lungpacer Medical Inc. during the conduct of the study and outside the submitted work. In addition, DE has multiple related patents issued and pending. DS reports personal fees from Lungpacer Medical Inc. during the conduct of the study. LC reports fees from Lungpacer Medical Inc. during the conduct of the study and other competing interests from Lungpacer Medical Inc. outside the submitted work. GJC reports grants from Boehringer Ingelheim, Novartis, AstraZeneca, Respironics, MedImmune, Actelion, Forest, Pearl, Ikaria, Aeris, PneumRx, and Pulmonx and other support from HGE Health Care Solutions, LLC, Almirall, Boehringer Ingelheim, and Holaira, all outside the submitted work. MD reports personal fees and non-financial support from Lungpacer Medical Inc. during the conduct of the study and personal fees and non-financial support from Pulsion Medical Systems outside the submitted work. MGA reports personal fees from Lungpacer Medical Inc. during the conduct of the study and grants and personal fees from Dräger Medical AG, GlaxoSmithKline (GSK), and GE Healthcare outside the submitted work. DMD reports other support as well as research funding and consulting fees from Lungpacer Medical Inc. during the conduct of the study. BJP reports personal fees from Lungpacer Medical Inc. during the conduct of the study. TN reports personal fees from Lungpacer Medical Inc. during the conduct of the study and personal fees from Lungpacer Medical Inc. outside the submitted work. TS reports personal fees from Lungpacer Medical Inc. during the conduct of the study and personal fees from AstraZeneca France, personal fees from Boehringer Ingelheim France, personal fees from GSK France, personal fees and non-financial support from Novartis France, personal fees from TEVA France, personal fees from Chiesi, personal fees from Pierre Fabre Médicament, and personal fees from Invacare France, outside the submitted work. In the domain of therapeutic phrenic stimulation, TS received honoraria from Synapse Biomedical to translate the DPS/NeurRx4 user’s manual from English to French in 2007, and from 2012 to 2016, Synapse Biomedical contributed to a fundraiser organized by TS to promote respiratory research. TS advised Synapse Biomedical about clinical protocols but did not receive any honoraria from this company. TS currently collaborates with another diaphragm pacing company (Neuroresp/Atrotech) in an advisory capacity, here also without any honoraria or any non-financial support. FL declares that he has no competing interests.
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