Berlin 2009

25 April 2009

The following notes were transcribed during the Open TCI Initiative Meeting in Berlin at the Second World Congress of Intravenous Anaesthesia-TCI Meeting.

Present: Steven Shafer, Thomas Schnider, Charles Minto, Danesh Gupta, Frédérique Servin, Tomei Kazama, Kenichi Masui, Paul Barash, Talmage Egan, Alfredo del Gaudio, Jose (?Surname), Luis Cortinez, Mark Hayman, Daniella Studnicska, Roberto Rostossi, Primitivo Rendon, Fabio Azzeri, Steen Keerner, Anne Marie Christensen, Elzbieta Magdalena Plocharska.

• Welcome by Dr Minto.
• Dr Minto opened the meeting and provided a brief background of the Open TCI Initiative and a brief tour of the opentci.org website.
• Overview of the two goals of the initiative; open source code and pk/pd data sharing. Prof Shafer indicated that he might be able to locate and post the mathematica code for the function.
• Dr Minto reiterated that this is an open group, but that all members should complete a disclosure statement. Disclaimer of Drs Minto & Schnider reviewed briefly.
• Prof Shafer reiterated the ground rules; anyone can contribute data, anyone can download data, there should be consensus opinion (might not be realistic, but that is the goal), results are freely available.
• Prof Shafer indicated that Dan Shultz of the FDA is very positive about how we should move forward. OpenTCI can provide ‘reasonable assurance’ required by the FDA. This is a novel concept that the agency respects.
• Results of the poll by OpenTCI members regarding ‘What organization should we affiliate with?’
  • Summary of different organizations IARS, EuroSIVA, WorldSIVA, etc.
  • Overwhelming consensus was that WorldSIVA would become the home society.
  • This was formalized at the Executive & Board meeting earlier in the meeting.
• All present support this decision unanimously.
• Data presently on the website reviewed by Prof Shafer.
  • Format outlined;
  • Link to publications.
  • The data are in Excel format.
  • A readme file.
  • A series of graphs (pdf) produced with R scripts.
• More data sets on the way – these include;
  • Data from Prof Talmage Egan study approved in the morbidly obese patients.
  • Prof Kazama very happy to contribute his data sets, which allows exploration of ethnicity effects on pharmacokinetic parameters.
  • Potentially a study by Pablo Sepulveda in obese patients.
  • Potentially, venous data from children by Michelle Struys.
  • Potentially, data from Prof Tony Gin.
• Discussion about a model for all patients, vs model for different groups, e.g., model for the obese, children, elderly. Prof Shafer makes the point that the user should not have to select the model.
• Frédérique Servin comments on the importance of the early data sampling, suggested as possible reason for the not-so-good performance of the Schwilden propofol model.
• Pump manufacturers are supportive of the concept. User selects drug and the pumps by different manufacturers should perform identically. Final model(s) likely to be used for many years.
• At this stage we do not have pharmacodynamic data for propofol on the website. Frédérique Servin has data for bolus dose propofol data and BIS as effect measure, manuscript is currently in review.
• Prof Shafer indicated that he would like to step down as director of the project. The group unanimously support Dr Charles Minto taking over as the this role.
• Safety perspective to be added to the goals of the OpenTCI Initiative.
  • Dr Paul Barash has discussed safety issues with Dan Shultz.
  • Frédérique Servin indicates that we should focus on marketed devices.
  • Prof Shafer points out that data from Stanpump experience also relevant.
  • Ideally, should include survey of the companies and users of the pumps.
• Prof Paul Barash agreed to be chair of a new WorldSIVA Safety Initiative. Discussion of small safety signals and importance of looking for this signal. Aim to produce manuscript(s) on the topic of Safety and Open TCI.[1]