Acute Severe Respiratory FailureWEAN SAFENCT03255109
WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE
An observational study of Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, run by European Society of Intensive Care Medicine at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Severe Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 11,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2017to 1 Dec 2018
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Due to the observational nature of the present study, patients enrolled in other observational/interventional study CAN be enrolled in the present study. We aim to collect a large "convenience sample", with > 5,000 patients. Based on the LUNG SAFE data (NCT02010073; JAMA, 2016 Jul 19;316(3):347), we can estimate to enroll about 11 patients invasively ventilated on Day 2 following intubation per participating ICU in a 4 week period. We are therefore targeting the enrollment of 500 registered ICUs (considering a 10% dropout)
Who may be able to join
- Screening: all patients admitted in the ICU and aged >16 will be screened daily
- A patient will be included if he/she is undergoing Invasive mechanical ventilation on the second morning (between 6am and 10 am) after initiation of mechanical ventilation or after ICU admission (if ventilation was already in place).
Who cannot join
- Lack of informed consent (where required)
- Patients already present in the ICU at the beginning of the study, independently of the form of ventilatory support
Trial locations and contacts
1 site in 1 country.
Belgium1 site
All Centres From All Over the World Willing to Contribute Are Welcome
Brussels
About this study
Official title: WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE)
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.
Read the detailed description
The purpose of this study is to describe, in a large population of ICU patients 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. It will answer the following questions:
- What are the current approaches taken to wean patients from invasive mechanical ventilation?
- What is the frequency of delayed weaning from invasive mechanical ventilation?
- What are the factors that are used to determine when patients are in the weaning phase?
- What are the barriers to effective weaning from invasive MV?
- What factors (patient, institutional, medical practice) contribute to failed attempts to wean from invasive mechanical ventilation?
- What is the impact of premorbid conditions on weaning from invasive MV?
- What is the utility of existing classifications for weaning from invasive MV?
- What is the impact of early versus delayed and/or failed weaning from invasive MV?
Patients will be screened for the study when undergoing mechanical ventilation and admitted in the ICU.
Day 1 will be defined as the first day when IMV commences Day 2 commences at 6-10am (fixed time point each day per ICU practice) after IMV commences. Patients undergoing invasive mechanical ventilation on the morning of day 1 will be screened for the study Patients still undergoing IMV on Day 2, will be enrolled in the study Patients not undergoing invasive mechanical ventilation or liberated from invasive mechanical ventilation on day 1 will be re-evaluated daily for the presence of inclusion criteria.
- Keywords
- Lung, acute, respiratory, distress, weaning, mechanical ventilation, respiratory infection
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients invasively ventilated in the last 24 hours
To describe the frequency of simple, difficult and prolonged weaning
Measured: 90 days or hospital discharge (whichever occurs first)
Secondary outcomes (1)
The current approaches taken to wean patients from invasive mechanical ventilation and impact on weaning duration
What are the factors ((patient, institutional, medical practice) that are used to determine when patients are in the weaning phase
Measured: 90 days or hospital discharge (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Oct 2017
- Primary completion31 May 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Severe Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,000 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- European Society of Intensive Care Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John LAFFEY, MD, Principal investigator, National University of Galway, Ireland and St Michael's Hospital-University of Toronto, CanadaGiacomo BELLANI, MD, Principal investigator, S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255109
- Sponsor's protocol ID
- WEAN SAFE
- Acronym
- WEAN SAFE
- Status last verified
- Feb 2019
- First submitted
- 9 Aug 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
PubMed 17962636McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.
PubMed 23215559Fagon JY, Chastre J, Vuagnat A, Trouillet JL, Novara A, Gibert C. Nosocomial pneumonia and mortality among patients in intensive care units. JAMA. 1996 Mar 20;275(11):866-9.
PubMed 8596225Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.
PubMed 9700126Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
PubMed 23641924Blackwood B, Alderdice F, Burns K, Cardwell C, Lavery G, O'Halloran P. Use of weaning protocols for reducing duration of mechanical ventilation in critically ill adult patients: Cochrane systematic review and meta-analysis. BMJ. 2011 Jan 13;342:c7237. doi: 10.1136/bmj.c7237.
PubMed 21233157Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
PubMed 8948561Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
PubMed 18191684Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PubMed 27626706Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Caldecott 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. Online ahead of print.
PubMed 42714473Caldecott 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. eCollection 2026.
PubMed 41938899Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.
PubMed 36693401
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE)
- ClinicalTrials.gov ID
- NCT03255109
- Acronym / sponsor ID
- WEAN SAFE / WEAN SAFE
- Keywords
- Lung, acute, respiratory, distress, weaning, mechanical ventilation, respiratory infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,000 participants (actual)
- Lead sponsor
- European Society of Intensive Care MedicineUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to describe, in a large population of ICU patients 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. It will answer the following questions:
- What are the current approaches taken to wean patients from invasive mechanical ventilation?
- What is the frequency of delayed weaning from invasive mechanical ventilation?
- What are the factors that are used to determine when patients are in the weaning phase?
- What are the barriers to effective weaning from invasive MV?
- What factors (patient, institutional, medical practice) contribute to failed attempts to wean from invasive mechanical ventilation?
- What is the impact of premorbid conditions on weaning from invasive MV?
- What is the utility of existing classifications for weaning from invasive MV?
- What is the impact of early versus delayed and/or failed weaning from invasive MV?
Patients will be screened for the study when undergoing mechanical ventilation and admitted in the ICU.
Day 1 will be defined as the first day when IMV commences Day 2 commences at 6-10am (fixed time point each day per ICU practice) after IMV commences. Patients undergoing invasive mechanical ventilation on the morning of day 1 will be screened for the study Patients still undergoing IMV on Day 2, will be enrolled in the study Patients not undergoing invasive mechanical ventilation or liberated from invasive mechanical ventilation on day 1 will be re-evaluated daily for the presence of inclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Due to the observational nature of the present study, patients enrolled in other observational/interventional study CAN be enrolled in the present study. We aim to collect a large "convenience sample", with > 5,000 patients. Based on the LUNG SAFE data (NCT02010073; JAMA, 2016 Jul 19;316(3):347), we can estimate to enroll about 11 patients invasively ventilated on Day 2 following intubation per participating ICU in a 4 week period. We are therefore targeting the enrollment of 500 registered ICUs (considering a 10% dropout)
Key inclusion criteria (2 listed)
- Screening: all patients admitted in the ICU and aged >16 will be screened daily
- A patient will be included if he/she is undergoing Invasive mechanical ventilation on the second morning (between 6am and 10 am) after initiation of mechanical ventilation or after ICU admission (if ventilation was already in place).
Key exclusion criteria (2 listed)
- Lack of informed consent (where required)
- Patients already present in the ICU at the beginning of the study, independently of the form of ventilatory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients invasively ventilated in the last 24 hours
Time frame: 90 days or hospital discharge (whichever occurs first)
To describe the frequency of simple, difficult and prolonged weaning
1 secondary outcome
The current approaches taken to wean patients from invasive mechanical ventilation and impact on weaning duration
Time frame: 90 days or hospital discharge (whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Background: PubMed 17962636Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
- Background: PubMed 23215559McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.
- Background: PubMed 8596225Fagon JY, Chastre J, Vuagnat A, Trouillet JL, Novara A, Gibert C. Nosocomial pneumonia and mortality among patients in intensive care units. JAMA. 1996 Mar 20;275(11):866-9.
- Background: PubMed 9700126Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.
- Background: PubMed 23641924Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
- Background: PubMed 21233157Blackwood B, Alderdice F, Burns K, Cardwell C, Lavery G, O'Halloran P. Use of weaning protocols for reducing duration of mechanical ventilation in critically ill adult patients: Cochrane systematic review and meta-analysis. BMJ. 2011 Jan 13;342:c7237. doi: 10.1136/bmj.c7237.
- Background: PubMed 8948561Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
- Background: PubMed 18191684Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Background: PubMed 27626706Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Derived from this study: PubMed 42714473Caldecott 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. Online ahead of print.
- webpage on Wean Safe where more useful details can be found such as the link to register your siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John LAFFEY, MD principal investigator
National University of Galway, Ireland and St Michael's Hospital-University of Toronto, Canada
Giacomo BELLANI, MD principal investigator
S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, run by European Society of Intensive Care Medicine at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients invasively ventilated in the last 24 hours (time frame: 90 days or hospital discharge (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255109, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.