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WEAN SAFE

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

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, Anaesthesia, School of Medicine, National University of Ireland Galway, Ireland.

The Wean Safe group is delighted to share all the WEAN SAFE associated publications:

Update 10 September 2026:

1. Caldecott R, Zhu Y, McNicholas BA, Rezoagli E, Taran S, Pham T, Heunks L, Bellani G, Brochard L, Simpkin AJ, Laffey JG; WEAN SAFE Investigators. Distinct weaning phenotypes in patients unsuccessful in weaning from invasive mechanical ventilation: a secondary analysis of the WEAN SAFE cohort. Intensive Care Med. 2026 Sep 9. doi: 10.1007/s00134-026-08592-2. Epub ahead of print. PMID: 42714473.

2. Caldecott R, Laffey K, Khazaei O, Zhu Y, McNicholas BA, Rezoagli E, Pham T, Heunks L, Bellani G, Brochard L, Simpkin AJ, Dres M, Navalesi P, Laffey JG; WEAN SAFE Investigators. Management and outcomes in women and men weaning from invasive mechanical ventilation: insights from the WEAN SAFE study. Ann Intensive Care. 2026 Feb 20;16:100037. doi: 10.1016/j.aicoj.2026.100037. PMID: 41938899; PMCID: PMC13045549.

3. Bell A, Kuriyama A, Khazaei O, McNicholas BA, Pham T, Heunks L, Bellani G, Brochard L, Simpkin AJ, Laffey JG; WEAN SAFE Investigators. Does obesity impact on weaning from invasive ventilation: a secondary analysis of the WEAN SAFE study. Ann Intensive Care. 2025 Oct 21;15(1):164. doi: 10.1186/s13613-025-01586-1. PMID: 41116142; PMCID: PMC12537622.

4. Khazaei O, Laffey CM, Sheerin R, McNicholas BA, Pham T, Heunks L, et al. Impact of comorbidities on management and outcomes of patients weaning from invasive mechanical ventilation: insights from the WEAN SAFE study. Crit Care. 2025 Mar 13;29(1):114.

5. Laffey CM, Sheerin R, Khazaei O, McNicholas BA, Pham T, Heunks L, et al. Impact of frailty and older age on weaning from invasive ventilation: a secondary analysis of the WEAN SAFE study. Ann Intensive Care. 2025 Jan 20;15(1):13.

6. Reep CAT, Wils EJ, Fleuren LM, Breskin A, Bellani G, Laffey JG, et al. Early vs. Delayed Switching from Controlled to Assisted Ventilation: A Target Trial Emulation. Am J Respir Crit Care Med. 2025 Jan 21;

7. Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, et al. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 Jan 20;S2213-2600(22)00449-0.

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.

Any questions? please write to jlaffey@universityofgalway.ieCall for Sub-Studies — Now Closed

The formal call for WEAN SAFE sub-study proposals is now closed. However, the Steering Committee will continue to consider ad hoc applications for use of the WEAN SAFE dataset on a case-by-case basis. Investigators interested in submitting an ad hoc proposal are welcome to contact the WEAN SAFE team directly.

Appendix: List of approved WEAN SAFE sub-studies (Stage 1, 2 and 3 calls)

  • Comparisons of Spontaneous Breathing Trials with Different Durations for Predicting Weaning Success (BREATH WEAN)
  • A weaning score to predict the duration of weaning.
  • Prognostic models for timely and successful weaning from ventilatory assistance (PROMISE WEANING).
  • 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).
  • Outcome of SBT failure.
  • Determining the attributable mortality of extubation failure.
  • Risk factors associated with reintubation among critically ill patients receiving invasive mechanical ventilation.
  • Patterns of use and failure rates of post-extubation non-invasive support in the intensive care unit.
  • Patient- and management characteristics associated with the occurrence of spontaneous breathing efforts.
  • Hospital outcomes of the patients tracheostomized during the mechanical ventilation weaning process and predictors of outcomes (TRACH-WEANSAFE).
  • Hospital level factors associated with weaning process: post-hoc analysis of WEAN SAFE STUDY.
  • Using Artificial intelligence to predict weaning and extubation success, explain delayed weaning, and develop clinical decision support tools (iWEAN SAFE)
  • Detailed analysis of impact of specific demographic factors (sex, Comorbidities, BMI), etc on the management and outcome of patients weaning from invasive MV
  • Sex and gendeR diffErences in the Practice of weAning from mechanical ventilation and the use of non-Invasive Respiratory Support after extubation (REPAIRS).
  • Geo-economic variations in weaning management and outcomes (GeoWEAN)
  • Weaning from ventilation in surgery vs non–surgical patients (WISdOM)
  • COmparative analysis of Mechanical ventilation weaning PAtterns in REspiratory diseases: WEANing strategies in COPD and ILD using the SAFE dataset (COMPARE-WEAN).
  • WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE in Acute Brain Injury
  • Digital twins of patients receiving HFNC during weaning patients from invasive mechanical ventilation (DigiT-HFNC)
  • Prevention of reintubation using high flow nasal cannula after weaning (HIGH WEAN)
  • RISK factors predicting the nEed for Non-invaSive ventilation for preventing post-extUbation REspiratory failure (ENSURE).

Note: In each of the above studies, analyses are ongoing and nearing completion at the present time.

Where overlapping proposals are received, we will work with the teams that propose them to determine how best to combine these proposals.

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.

Any questions? please write to john.laffey [at] universityofgalway.ie

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