- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363231
Maximal Inspiratory Pressure at Extubation: Relationship With Mortality
January 8, 2016 updated by: BOUCHRA LAMIA, University Hospital, Rouen
The process of weaning from mechanical ventilation was decided after clinical judgment and weaning predictive index.
Nevertheless, indexes predicting weaning outcome like Maximal Inspiratory Pressure (MIP) are frequently inaccurate.
However the long-term involvement of respiratory muscles in critically ill patients has not been established.
The objective of this study was to assess the relationship on MIP at extubation on one-year mortality in critically ill patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
124
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
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Montivilliers, France, 76290
- Le Havre, Jacques Monod Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Critically ill patient under invasive mechanical ventilation
Description
Inclusion Criteria:
- Mechanical ventilation at least at 24 hours
Exclusion Criteria:
- Delirium
- Cognitive dysfunction
- refusal to participate
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
Cohorts and Interventions
Group / Cohort |
|---|
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patients under mechanical ventilation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mortality
Time Frame: One year after extubation
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One year after extubation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to mechanical ventilation weaning
Time Frame: During Intensive care unit hospitalization
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During Intensive care unit hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clement Medrinal, Groupe Hospitalier Du Havre
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
- Combret Y, Prieur G, Hilfiker R, Gravier FE, Smondack P, Contal O, Lamia B, Bonnevie T, Medrinal C. The relationship between maximal expiratory pressure values and critical outcomes in mechanically ventilated patients: a post hoc analysis of an observational study. Ann Intensive Care. 2021 Jan 13;11(1):8. doi: 10.1186/s13613-020-00791-4.
- Medrinal C, Prieur G, Combret Y, Quesada AR, Bonnevie T, Gravier FE, Frenoy E, Contal O, Lamia B. Reliability of respiratory pressure measurements in ventilated and non-ventilated patients in ICU: an observational study. Ann Intensive Care. 2018 Jan 30;8(1):14. doi: 10.1186/s13613-018-0362-1.
- Medrinal C, Prieur G, Frenoy E, Robledo Quesada A, Poncet A, Bonnevie T, Gravier FE, Lamia B, Contal O. Respiratory weakness after mechanical ventilation is associated with one-year mortality - a prospective study. Crit Care. 2016 Jul 31;20(1):231. doi: 10.1186/s13054-016-1418-y.
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
January 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
February 9, 2015
First Submitted That Met QC Criteria
February 9, 2015
First Posted (Estimate)
February 13, 2015
Study Record Updates
Last Update Posted (Estimate)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 8, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2013-A01157-38
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.