Acute Respiratory InsufficiencyNEUROMIENCT01931228
Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy
A study testing MI-E plus manually assisted coughing and manually assisted coughing in people with Acute Respiratory Insufficiency and Respiratory Failure, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Insufficiency, Respiratory Failure
- What is being tested?
- MI-E plus manually assisted coughing and manually assisted coughing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2012to May 2016
- Phase
- Interventional
- 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
Who may be able to join
- Male or female patient aged ≥ 18 years.
- Patient admitted in participant ICU.
- Patient intubated for 48 hours at least.
- Patient presenting an ICU acquired neuromuscular disorders.
Who cannot join
- Respiratory or haemodynamic instability.
- Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,…) gastroesophageal surgery.
- Severe ventricular rhythm disorders.
- Patient with tracheotomy.
- Uncontrollable vomiting.
- Severe sepsis.
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- Upper airway disorders.
- Upper gastrointestinal bleeding.
- Any decision to limit therapeutic effort in the ICU.
- Patient with limit therapeutic effort in the ICU with unsuccessful spontaneous respiratory trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy
Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.
the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing
Read the detailed description
Critical Care Neuromyopathy (CCN) occur in 25% of patient in Intensive Care Unit (ICU). Respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. Respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. Currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. Despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. MI-E has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. So the beneficials effects of MI-E should be confirmed in a trial in this specific population.
We planned to conduct a study evaluating the efficacy of MI-E in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to MI-E group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU or 28-day survival,90-day survival, ICU length of stay.
- Being tested
- MI-E plus manually assisted coughing, manually assisted coughing
- Keywords
- Intensive care unit, acute respiratory insufficiency, Respiratory failure, Mechanical Insufflation-Exsufflation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-E plus manually assisted coughingProcedure or surgery
MI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.
manually assisted coughingProcedure or surgery
Manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.
| Study group | Role | What they receive |
|---|---|---|
| MI-E plus manually assisted coughing | Experimental | Not described Receives: Procedure: MI-E plus manually assisted coughing |
| Manually assisted coughing only | Experimental | Not described Receives: Procedure: manually assisted coughing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory failure after extubation
Measured: 48h post extubation (48h after inclusion)
Secondary outcomes (7)
the increase in peak cough flow
Measured: End of intensive care or day 28 after inclusion
the incidence of reintubation
Measured: End of intensive care or day 28 after inclusion
the average time of hospitalization in the intensive care unit
Measured: End of intensive care or day 28 after inclusion
the incidence of nasotracheal suction
Measured: End of intensive care or day 28 after inclusion
the number of additional physiotherapy sessions
Measured: End of intensive care or day 28 after inclusion
the ICU mortality or 28-day survival
Measured: 28 days after inclusion
90 days survival
Measured: 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start3 May 2012
- Primary completionFeb 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe WIBART, Physical therapist, Principal investigator, University Hospital, BordeauxAntoine BENARD, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931228
- Sponsor's protocol ID
- CHUBX 2011/21
- Acronym
- NEUROMIE
- Status last verified
- Jan 2018
- First submitted
- 22 Aug 2013
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wibart P, Reginault T, Garcia-Fontan M, Barbrel B, Bader C, Benard A, Parreira VF, Gonzalez-Anton D, Bui NH, Gruson D, Hilbert G, Martinez-Alejos R, Vargas F. Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial. Crit Care Sci. 2023 Apr-Jun;35(2):168-176. doi: 10.5935/2965-2774.20230410-en.
PubMed 37712806
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy
- ClinicalTrials.gov ID
- NCT01931228
- Acronym / sponsor ID
- NEUROMIE / CHUBX 2011/21
- Keywords
- Intensive care unit, acute respiratory insufficiency, Respiratory failure, Mechanical Insufflation-Exsufflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 May 2012 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Aug 2013 (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.
Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.
the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing
Detailed description
Critical Care Neuromyopathy (CCN) occur in 25% of patient in Intensive Care Unit (ICU). Respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. Respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. Currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. Despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. MI-E has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. So the beneficials effects of MI-E should be confirmed in a trial in this specific population.
We planned to conduct a study evaluating the efficacy of MI-E in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to MI-E group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU or 28-day survival,90-day survival, ICU length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI-E plus manually assisted coughing | Experimental | Procedure: MI-E plus manually assisted coughing |
| Manually assisted coughing only | Experimental | Procedure: manually assisted coughing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient aged ≥ 18 years.
- Patient admitted in participant ICU.
- Patient intubated for 48 hours at least.
- Patient presenting an ICU acquired neuromuscular disorders.
Key exclusion criteria (10 listed)
- Respiratory or haemodynamic instability.
- Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,…) gastroesophageal surgery.
- Severe ventricular rhythm disorders.
- Patient with tracheotomy.
- Uncontrollable vomiting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI-E plus manually assisted coughingMI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session. | Procedure or surgery | MI-E plus manually assisted coughing |
| manually assisted coughingManually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session. | Procedure or surgery | Manually assisted coughing only |
Primary outcome
Incidence of respiratory failure after extubation
Time frame: 48h post extubation (48h after inclusion)
7 secondary outcomes
the increase in peak cough flow
Time frame: End of intensive care or day 28 after inclusion
the incidence of reintubation
Time frame: End of intensive care or day 28 after inclusion
the average time of hospitalization in the intensive care unit
Time frame: End of intensive care or day 28 after inclusion
the incidence of nasotracheal suction
Time frame: End of intensive care or day 28 after inclusion
the number of additional physiotherapy sessions
Time frame: End of intensive care or day 28 after inclusion
the ICU mortality or 28-day survival
Time frame: 28 days after inclusion
90 days survival
Time frame: 90 days after inclusion
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 23 Jan 2018.
- Derived from this study: PubMed 37712806Wibart P, Reginault T, Garcia-Fontan M, Barbrel B, Bader C, Benard A, Parreira VF, Gonzalez-Anton D, Bui NH, Gruson D, Hilbert G, Martinez-Alejos R, Vargas F. Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial. Crit Care Sci. 2023 Apr-Jun;35(2):168-176. doi: 10.5935/2965-2774.20230410-en.
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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.
Philippe WIBART, Physical therapist principal investigator
University Hospital, Bordeaux
Antoine BENARD, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-E plus manually assisted coughing and manually assisted coughing in people with Acute Respiratory Insufficiency and Respiratory Failure, run by University Hospital, Bordeaux 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 4 inclusion and 10 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 23 Jan 2018. 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?
Incidence of respiratory failure after extubation (time frame: 48h post extubation (48h after inclusion)). 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 NCT01931228, which also lists 1 linked publication.
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 23 Jan 2018.