PROVHILO - Physicians

 

Protective ventilation with high or low
positive end-expiratory pressure
 
Protective Ventilation During General Anesthesia for Open Abdominal Surgery
Randomized Controlled Trial
                                         

Welcome to the PROVHILO website!

Thank you for your participation in the PROVHILO collaboration.
On this site you will find all information and study documents on the trial.
 
If you have any questions, please email: provhilotrial@gmail.com
Sabrine Hemmes, Trial Coordinator
 

PROVHILO News

  • PROVHILO accepted in The LANCET!
    The final manuscript of PROVHILO has been accepted for publication in The Lancet!
    Congratulations to all PROVHILO Investigators and many thanks for all their efforts and hard work. 
    Together we have made this trial to a great success, and have given an answer to one of the essential discussions within mechanical ventilation: to PEEP or not to PEEP?




















    Posted Mar 7, 2014, 12:40 AM by Sabrine Hemmes
  • PROVHILO inclusion finished!
    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
    Posted Jan 14, 2013, 12:36 AM by Sabrine Hemmes
  • Inform PROVHILO patients on trial end

    Just 22 patients to go, until we reach 900 inclusions!

    Please continue your patient inclusion. We expect to finish approximately end of January.

    If your center recruits patients in the out-patient department days/ weeks prior to surgery, please inform those patients that the end of the trial is near and it might be possible that the trial will have stopped at their day of surgery. If this is the case, the patient will be treated according to standard care, as provided in your hospital.
    Posted Jan 4, 2013, 6:52 AM by Sabrine Hemmes
  • Merry Christmas!!!
    We want to wish everyone a very Merry Christmas and Happy Holidays!!
    Many thanks to all the investigators for their great work during the past 2 years.
    2013 is going to be an exciting year for the PROVHILO Collaboration!
    Posted Dec 24, 2012, 4:28 AM by Sabrine Hemmes
  • DSMB review - 600 patients
    The DSMB has reviewed the Interim Analysis and (serious) adverse events of the 600 included patients on a "Group A" versus "Group B" basis.
    They recommend continuing the PROVHILO trial.
     
    DSMB members:
    - prof. Dan Sessler (chair)
    - prof. Arthur Slutsky
    - prof. Robert Kacmarek
    - prof. Burkhard Lachmann 
    Posted Sep 25, 2012, 8:51 AM by Sabrine Hemmes
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