Great news; we have reached inclusion of 900 patients!! Congratulations to everyone for this fantastic achievement. PROVHILO is the largest randomized controlled trial in mechanical ventilation ever performed in Anesthesia. Well done to all!!
We are very impressed by the commitment of all PROVHILO centers to the trial. We hope to continue to perform large trials and answer important clinical questions with this extraordinary network.
We would like your attention for the following: 1. PROVHILO is closed; it is not allowed to randomize and/or treat anymore patients within the PROVHILO study. If you have an substudy running with local EC approval, it is allowed to continue the "PROVHILO" MV-interventions, but these patients will not fall under the PROVHILO cohort anymore (scientifically nor legally).
2. Please complete your data-entry in the eCRF. Many centers are (almost) finished, but a few centers still have a lot of work to do.
3. In centers with completed data-entry, we will start with data cleaning soon. In case of questions regarding your data entry, we will send you an email with the queries.
4. Data monitoring shall be performed on site by an independent monitor, in a randomly selected cohort of centers. You will be informed in the next weeks if your center is selected for monitoring.
Again our greatest compliments to all! We are extremely proud of the achievement of the PROVHILO collaboration.
Warmest regards, Sabrine Hemmes Marcus Schultz Marcelo Gama de Abreu Paolo Pelosi |