« PhEAST documents

PhEAST logo  

PhEAST trial – Pharyngeal Electrical Stimulation for Acute Stroke dysphagia Trial

Trial documents

SA-01-22

 

SA-01-22

  1. This amendment comprises of updates to the inclusion and exclusion criteria, regarding the consciousness levels of potential participants (NIHSS score added for clarification of which participants can be recruited); the disposition of the participant at day 14 primary outcome (participants need to be in treating organisation for this) and a change to the oxygen levels in the exclusion criteria (up to 35 litres deemed safe with the use of PES).
  2. This amendment also comprises of various administrative changes; namely a protocol version table has been added, the WHO ID added to the front page, and sentences throughout the protocol added for clarification.
  3. This amendment also extends the Serious Adverse Event Collection from days 0-7 to days 0-9 to account for the change in the participant treatment schedule, whereby participants can have three days of treatment followed by a 1 or 2 day break, followed by another three days of treatment, to ensure sites that do not operate at weekends can recruit and treat eligible patients.
  4. Finally, an appendix has been added at the behest of the Austrian ethics committee, to outline their consent procedure that will be approved and followed in Austrian sites.



Switch to mobile site