WEAN SAFE Study – WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE

Update 5 July 2023: Call for secondary studies

The first call for WEAN SAFE substudies opened on March 10th. ‘This call invited members of the WEAN SAFE Steering committees and the  National Coordinators to submit proposals. The sub-studies were evaluated by the WEAN SAFE Executive, and studies in the list below have been approved, and will now commence.

The second call, in which all WEAN SAFE investigators will have the possibility to submit proposals, will open on October 1st 2023 for a period of 2 months. We will post details of how to make these proposals closer to the call opening date.

List of approved WEAN SAFE sub-studies from Stage 1 call

  1. A weaning score to predict the duration of weaning
  2. Prognostic models for timely and successful weaning from ventilatory assistance (PROMISE WEANING)
  3. Pressure support ventilation versus T-piece as first attempt of spontaneous breathing trial (SBT) for the weaning of intubated patients in the WEAN-SAFE study (WEAN SAFE SBT)
  4. Predicting and scoring the risk of Extubation failure
  5. Determining the attributable mortality of extubation failure
  6. Risk factors associated with reintubation among critically ill patients receiving invasive mechanical ventilation
  7. Patterns of use and failure rates of post-extubation non-invasive support in the intensive care unit
  8. Patient- and management characteristics associated with the occurrence of spontaneous breathing efforts.
  9. The Effects of Early vs. Late Switching to Assisted Ventilation Mode in Mechanically Ventilated Patients: A Target Trial Emulation
  10. WEaning from Mechanical vEntilation in cRiticAlly ill in fraiL and elDerly patients (EMERALD)
  11. Hospital outcomes of the patients tracheostomized during the mechanical ventilation weaning process and predictors of outcomes (TRACH-WEANSAFE)
  12. Hospital level factors associated with weaning process: post-hoc analysis of WEAN SAFE STUDY
  13. Using Artificial intelligence to predict weaning and extubation success, explain delayed weaning, and develop clinical decision support tools (iWEAN SAFE)

Update  13 April 2023:
Call for secondary studies

Step 1 of the call, which opened on March 10th, is now closed.

In this step, members of the WEAN SAFE Executive and Steering committees and National Coordinators will have a period of four weeks following publication of this call on the ESICM website to submit their proposals.

In step 2, all WEAN SAFE investigators will have the possibility to submit proposals. We will open that call shortly, via an announcement on this website.

Update  13 March 2023:

The Wean Safe Executive committee is delighted to invite WEAN SAFE investigators to submit suggestions for additional analyses that would result in secondary publications and presentations.  This formal invitation to submit proposals is being issued in three steps.

Step 1 of the call is being opened now. In this step, members of the WEAN SAFE Executive and Steering committees and National Coordinators will have a period of four weeks following publication of this call on the ESICM website to submit their proposals.

In step 2, which will open in 4 weeks, the WEAN SAFE investigators will have the possibility to submit proposals. At a later stage, in step 3, a general call will be issued to the research community where all researchers can make study proposals. Thereafter, general calls for proposals will be issued periodically (2-3 times a year). Each call will have a deadline. The WEAN SAFE Executive committee will meet after each deadline to evaluate and rank proposals and give feedback to the authors of the proposals.

These proposals will be evaluated by the Executive Committee. Proposals from WEAN SAFE investigators (i.e., site investigators and national coordinators) will take priority. We anticipate that all requests for scientifically sound sub-analyses will be approved by the Executive Committee.

The titles of approved (and hence undergoing) proposals will be posted on this webpage, to facilitate further applicants in avoiding overlaps.

Our OPEN WEAN SAFE policy is available HERE, which provides further details on the evaluation process for proposals. A study proposal form is available HERE, and must be used for all such proposals.

Submit your proposal  to  john.laffey [at] universityofgalway.ie using this specific form before 6 April 2023.

Update 21 January 2023:
 Publication of the primary paper.

Tài Pham, Leo Heunks, Giacomo Bellani, et al. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Published online on 21 January 2023 in Lancet Respir Med. ;  https://doi.org/10.1016/S2213-2600(22)00449-0

In this paper, the following key findings are reported:

  • Only 65% of patients who required ventilation for longer than two days were successfully weaned from invasive mechanical ventilation
  • Of patients who entered the weaning process, 65% had a short wean (≤1 day), 10% had intermediate (2-6 days) weaning, 10% had a prolonged (≥ 7 days) weaning duration, while 16% ultimately failed (i.e., died, were transferred or still invasively ventilated at day 90).
  • Higher sedation levels were independently associated with delays in initiating weaning from the ventilator.
  • Higher sedation levels and a delay in initiating ventilator separation were potentially modifiable factors independently associated with weaning failure.
  • Of the patients enrolled, 30% died in the ICU, while 38% died in hospital.

What?

WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a multi-centre, prospective, observational, 4-week inception cohort study being carried out by the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for intensivists and patients spend a considerable amount of time in being liberated from mechanical ventilation. While guidelines do exist on the classification of weaning, a recent study has shown that these may not be applicable to all patients. Moreover, different practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the burden of, management and spectrum of approaches to weaning from ventilation, in patients that require invasive mechanical ventilation for any reason, for a time period of at least 24 hours.

When?

The study  has been performed over a 4 week period between October 1st 2017 and May 31st 2018 in ICUs across the world.

Co-Principal Investigators

Giacomo Bellani, A.O. San Gerardo, Monza, University of Milan Bicocca, Italy

John Laffey, Departments of Anesthesia and Critical Care Medicine, St. Michael’s Hospital, Toronto, Canada; Anaesthesia, School of Medicine, National University of Ireland Galway, Ireland.

Media

In this icTV interview (March 2018), John Laffey discusses the progress of WEAN SAFE study and encourages centres to get actively involved in this important ESICM Trials Group initiative.

Contact

For more information, please contact research@esicm.org