Funding for this research was provided by:
Royal Devon and Exeter NHS Foundation Trust (17-019)
Article History
Received: 5 August 2019
Accepted: 14 May 2020
First Online: 25 May 2020
Ethics approval and consent to participate
: Ethical approval for the study was received from Oxford C Research Ethics Committee (Ref 17/SC/0111). All participants included in the study consented to take part and have their data used.
: The Royal Devon and Exeter Hospital NHS Foundation Trust introduced the concept of the valsalva assist device to Meditech Systems Limited, advised on refinements to the device and as such, the trust has a royalty agreement on future sales of the device. None of the research team have received or currently stand to gain personal financial benefit from Meditech, are shareholders or have any direct financial interest in the company. Meditech had no involvement in the funding, design, analysis or interpretation of the study nor any role in the publication of its findings.