ANZICS CTG Supported Study

WEAN SAFE

Worldwide assessment of separation of patients from ventilatory assistance

Study Description

WEAN SAFE is a multi-centre study being carried out by the Acute Respiratory Failure section of the European Society of Intensive Care Medicine. This is an observational study examining the weaning of patients from invasive mechanical ventilation.

Management Committee

Giacomo Bellani (Co-Chair), John Laffey (Co-Chair), Tài Pham, Leo Heunks, and Laurent Brochard.

Project Manager

Frank van Haren (Australian Investigator & Manager)

Administering Institution

European Society of Intensive Care Medicine

Collaborators

Medical Research Institute of New Zealand

Sample Size

5000 patients

Funding

ESICM (Project support for data analysis) €11,000.

Project Status as of June 2018

This study has been well participated in across Australia and New Zealand. Many sites did not obtain RGO approval until the last minute therefore some of the sites that have registered have not yet completed the eCRF entry on the database. There have been minor queries regarding the enrolment period but apart from that there have been no issues with this study. There have been no data breaches or any other issues. The recruitment period was extended from March until May for the southern hemisphere to allow sites time to be activated. There is a 90 day follow-up required for each participant with the last day being the 31st of August.

There have been no ethical concerns with this study.

Contact

Frank van Haren (email)

Reference

CTG1718-02
NCT03255109