An observational study in Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, sponsored by European Society of Intensive Care Medicine. Completed at 1 site in Belgium. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by European Society of Intensive Care Medicine · Observational
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.
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:
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 11,000 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →European Society of Intensive Care Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Screening: all patients admitted in the ICU and aged >16 will be screened daily
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of patients invasively ventilated in the last 24 hours
To describe the frequency of simple, difficult and prolonged weaning
Time frame: 90 days or hospital discharge (whichever occurs first)
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
Time frame: 90 days or hospital discharge (whichever occurs first)
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome →
European Society of Intensive Care Medicine