Post-extubation FailureMIEICUNCT01424202
Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
A study testing Mechanical Insufflation Exsufflation in people with Post-extubation Failure and Persistent Weaning Failure, run by Hospital Sao Joao at 1 site in Portugal.
Trial summary
Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-extubation Failure, Persistent Weaning Failure, Secretion Encumbrance
- What is being tested?
- Mechanical Insufflation Exsufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2008to Oct 2010
- 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
- Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology
Who cannot join
- facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João
Porto, Porto District, 4200-319
About this study
Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.
In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.
Read the detailed description
Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.
Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.
- Conditions
- Post-extubation Failure, Persistent Weaning Failure, Secretion Encumbrance, Weak Cough, Ventilatory Failure
- Being tested
- Mechanical Insufflation Exsufflation
- Keywords
- Post extubation failure, Mechanical Insufflation-Exsufflation, Noninvasive Ventilation, Weaning
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Insufflation ExsufflationDevice
After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle.
On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions.
The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E). Receives: Device: Mechanical Insufflation Exsufflation |
| Group A | No intervention | Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-intubation rates
Measured: 48 hours
Secondary outcomes (1)
NIV failure rates
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionOct 2010
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 Post-extubation FailureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel R. Goncalves, Hospital Sao Joao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424202
- Sponsor's protocol ID
- MIEICU-08112010
- Acronym
- MIEICU
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
PubMed 15190137
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
- ClinicalTrials.gov ID
- NCT01424202
- Acronym / sponsor ID
- MIEICU / MIEICU-08112010
- Conditions
- Post-extubation Failure, Persistent Weaning Failure, Secretion Encumbrance, Weak Cough, Ventilatory Failure
- Keywords
- Post extubation failure, Mechanical Insufflation-Exsufflation, Noninvasive Ventilation, Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Aug 2011 (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.
Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.
In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.
Detailed description
Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.
Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Device: Mechanical Insufflation ExsufflationPatients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E). |
| Group A | No intervention | –Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology
Key exclusion criteria (1 listed)
- facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.
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 |
|---|---|---|
| Mechanical Insufflation ExsufflationAfter passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle. On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions. The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse. | Device | Group B |
Primary outcome
re-intubation rates
Time frame: 48 hours
1 secondary outcome
NIV failure rates
Time frame: 48 hours
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 26 Aug 2011.
- Results publication: PubMed 15190137Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Insufflation Exsufflation in people with Post-extubation Failure and Persistent Weaning Failure, run by Hospital Sao Joao at 1 site in Portugal.
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 1 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 26 Aug 2011. 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 Portugal. 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?
re-intubation rates (time frame: 48 hours). 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 NCT01424202, 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 26 Aug 2011.