Mechanical VentilationNCT02363231
Maximal Inspiratory Pressure at Extubation: Relationship With Mortality
An observational study of Mechanical Ventilation, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patient under invasive mechanical ventilation
Who may be able to join
- Mechanical ventilation at least at 24 hours
Who cannot join
- Delirium
- Cognitive dysfunction
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients under mechanical ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: One year after extubation
Secondary outcomes (1)
Time to mechanical ventilation weaning
Measured: During Intensive care unit hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOUCHRA LAMIA, University Hospital, Rouen
- Investigators
- Clement Medrinal, Principal investigator, Groupe Hospitalier du Havre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363231
- Sponsor's protocol ID
- 2013-A01157-38
- Status last verified
- Jan 2016
- First submitted
- 9 Feb 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33438092Medrinal 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.
PubMed 29380080Medrinal 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.
PubMed 27475524
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Inspiratory Pressure at Extubation: Relationship With Mortality
- ClinicalTrials.gov ID
- NCT02363231
- Acronym / sponsor ID
- 2013-A01157-38
- Conditions
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Feb 2015 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients under mechanical ventilation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patient under invasive mechanical ventilation
Key inclusion criteria (1 listed)
- Mechanical ventilation at least at 24 hours
Key exclusion criteria (3 listed)
- Delirium
- Cognitive dysfunction
- refusal to participate
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
Mortality
Time frame: One year after extubation
1 secondary outcome
Time to mechanical ventilation weaning
Time frame: During Intensive care unit hospitalization
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 Jan 2016.
- Derived from this study: PubMed 33438092Combret 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.
- Derived from this study: PubMed 29380080Medrinal 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.
- Derived from this study: PubMed 27475524Medrinal 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.
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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.
Clement Medrinal principal investigator
Groupe Hospitalier du Havre
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 Mechanical Ventilation, run by University Hospital, Rouen at 1 site in France.
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 1 inclusion and 3 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 Jan 2016. 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 France. 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?
Mortality (time frame: One year after extubation). 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 NCT02363231, which also lists 3 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 Jan 2016.