WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE (WEAN SAFE)

February 11, 2019 updated by: European Society of Intensive Care Medicine

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

11000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • All Centres From All Over the World Willing to Contribute Are Welcome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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)

Description

Inclusion Criteria:

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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days or hospital discharge (whichever occurs first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days or hospital discharge (whichever occurs first)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Intensive Care Medicine

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEAN SAFE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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