MortalityNCT04149873
Effectness of Treatment With Mechanical Insufflation-Exsufflation
A study testing MIE in people with Mortality, run by Chimei Medical Center at 1 site in Taiwan.
Trial summary
Patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mortality
- What is being tested?
- MIE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to 31 Dec 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Written Informed Consent given by the patient or, if not possible, by a legally authorized representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
- 2.To be at least 20 years of age.
- 3.To be treated in an ICU at the time of enrollment.
- 4.Endotracheal tube in place
- 5.The patient is mechanically ventilated and reach:
- Ventialtopr: Pressure support mode
- reach 6-8CC/IBW, ideal body weight for 24 hours
- MEP, maximum expiratory pressure < 60cmH2O
Who cannot join
- 1.The patient or legally authorized representative refuse
- 2.< 20 years of age.
- 3.Neither endotracheal tube nor mechanical ventilator use
- 4.The patient is mechanically ventilated, but:
- The ventialtopr mode NOT: Pressure support mode
- No reach 6-8CC/IBW, ideal body weight for 24 hours
- MEP, maximum expiratory pressure > 60cmH2O
- 5.Participation as subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Intensive Care Medicine; Chi Mei Medical Center
Tainan, 710
About this study
Official title: Effectness of Treatment With Mechanical Insufflation-Exsufflation in Surgical Critically Ill Patients With Impaired Cough Function
Patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.
Read the detailed description
Endotracheal intubation and mechanical ventilation are always used to treat acute respiratory failure in critically ill patients. Successful weaning from ventilator and extubation are crucial to determine the prognosis when patient's underlying disease getting improvement. The reasons for extubation failure include lack of improvement of on the work of breathing, hypoxemia, respiratory acidosis, conscious disturbance and retained respiratory secretions, etc. In our clinical practice, the factor of retained respiratory secretions plays an important role in successful extubation.
Traditional chest physiotherapy (CPT) is commonly used to help the critically patients in the effective expulsion of airway secretions. In recent years, new advanced techniques mechanical insufflations-exsufflation (MI-E) and high frequency chest wall oscillation (HFCWO)have been developed to get more effective to remove secretions for patients suffered from acute respiratory failure. The above devices have been described as an effective techniques for patients with chronic neuromuscular weakness, cystic fibrosis and bronchiectasis. By the knowledge, only one study mentioned about MI-E could reduce the reintubation rate and shorten the ICU length of stay. But its limitations include less of case number and not focusing on impaired cough function patients.
In this study, patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.
- Conditions
- Mortality
- Being tested
- MIE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIEProcedure or surgery
MIE
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group' has the treatment with [Physical chest care ] Receives: Procedure: MIE |
| Experimental group-A | Placebo comparator | 'Experimental group-A' has the treatment with [Mechanical-Insufflation- Exsufflation] Receives: Procedure: MIE |
| Experimental group-B | Experimental | 'Experimental group-B' has the treatment with [Mechanical-Insufflation- Exsufflation] and [Physical chest care] Receives: Procedure: MIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
One year mortality rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startSep 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuo-Chen Cheng, Chimei Medical Center
- Investigators
- Kuo-Chen Cheng, Chief, Study chair, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149873
- Sponsor's protocol ID
- CMFHR 10460(IRB10407-008)
- Status last verified
- Oct 2019
- First submitted
- 24 Jan 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectness of Treatment With Mechanical Insufflation-Exsufflation in Surgical Critically Ill Patients With Impaired Cough Function
- ClinicalTrials.gov ID
- NCT04149873
- Acronym / sponsor ID
- CMFHR 10460(IRB10407-008)
- Conditions
- Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 4 Nov 2019 (actual)
- 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.
Patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.
Detailed description
Endotracheal intubation and mechanical ventilation are always used to treat acute respiratory failure in critically ill patients. Successful weaning from ventilator and extubation are crucial to determine the prognosis when patient's underlying disease getting improvement. The reasons for extubation failure include lack of improvement of on the work of breathing, hypoxemia, respiratory acidosis, conscious disturbance and retained respiratory secretions, etc. In our clinical practice, the factor of retained respiratory secretions plays an important role in successful extubation.
Traditional chest physiotherapy (CPT) is commonly used to help the critically patients in the effective expulsion of airway secretions. In recent years, new advanced techniques mechanical insufflations-exsufflation (MI-E) and high frequency chest wall oscillation (HFCWO)have been developed to get more effective to remove secretions for patients suffered from acute respiratory failure. The above devices have been described as an effective techniques for patients with chronic neuromuscular weakness, cystic fibrosis and bronchiectasis. By the knowledge, only one study mentioned about MI-E could reduce the reintubation rate and shorten the ICU length of stay. But its limitations include less of case number and not focusing on impaired cough function patients.
In this study, patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: MIEControl group' has the treatment with [Physical chest care ] |
| Experimental group-A | Placebo comparator | Procedure: MIE'Experimental group-A' has the treatment with [Mechanical-Insufflation- Exsufflation] |
| Experimental group-B | Experimental | Procedure: MIE'Experimental group-B' has the treatment with [Mechanical-Insufflation- Exsufflation] and [Physical chest care] |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.Written Informed Consent given by the patient or, if not possible, by a legally authorized representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
- 2.To be at least 20 years of age.
- 3.To be treated in an ICU at the time of enrollment.
- 4.Endotracheal tube in place
- 5.The patient is mechanically ventilated and reach:
Key exclusion criteria (8 listed)
- 1.The patient or legally authorized representative refuse
- 2.< 20 years of age.
- 3.Neither endotracheal tube nor mechanical ventilator use
- 4.The patient is mechanically ventilated, but:
- 5.Participation as subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.
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 |
|---|---|---|
| MIEMIE | Procedure or surgery | Control group, Experimental group-A, Experimental group-B |
Primary outcome
mortality rate
Time frame: 1 year
One year mortality rate
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 4 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Kuo-Chen Cheng, Chief study chair
Chi Mei Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIE in people with Mortality, run by Chimei Medical Center at 1 site in Taiwan.
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 8 inclusion and 8 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 4 Nov 2019. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2019.