WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE (WEAN SAFE)
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|ClinicalTrials.gov Identifier: NCT03255109|
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : February 12, 2019
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|Condition or disease|
|Acute Severe Respiratory Failure Acute Respiratory Distress Syndrome|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||11000 participants|
|Target Follow-Up Duration:||90 Days|
|Official Title:||WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE)|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||December 1, 2018|
- 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
- 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) ]What are the factors ((patient, institutional, medical practice) that are used to determine when patients are in the weaning phase
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Probability Sample|
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)
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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255109
|All Centres From All Over the World Willing to Contribute Are Welcome|
|Principal Investigator:||John LAFFEY, MD||National University of Galway, Ireland and St Michael's Hospital-University of Toronto, Canada|
|Principal Investigator:||Giacomo BELLANI, MD||S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy|
|Responsible Party:||European Society of Intensive Care Medicine|
|Other Study ID Numbers:||
|First Posted:||August 21, 2017 Key Record Dates|
|Last Update Posted:||February 12, 2019|
|Last Verified:||February 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases