Ventilator DependencyIMTNCT03997214
The Impact of Inspiratory Muscle Strength Training
A study testing inspiratory muscle strength training in people with Ventilator Dependency, run by Fooyin University at 1 site in Taiwan.
Trial summary
The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilator Dependency
- What is being tested?
- inspiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2018to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >20y/o
- Vital signs stable
- MIP <20cmH2O
- Ventilator FiO2<40%, PEEP <8
- Ventilator mode:PSV or SIMV
Who cannot join
- Patient or family refuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Inspiratory Muscle Strength Training on Weaning Parameters Among Ventilator-dependent Patients
The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.
- Conditions
- Ventilator Dependency
- Being tested
- inspiratory muscle strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle strength trainingDevice
The experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | as usual care |
| experimental group | Experimental | The intervention of inspiratory muscle strength training Receives: Device: inspiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
a measure of the strength of inspiratory muscles, measurement by cmH2O.
Measured: 7 weeks
Tidal volume
the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration
Measured: 7 weeks
Minute ventilation volume
the quantity of air moved into and out of the lungs in a minute, measurement by l.min
Measured: 7 weeks
Rapid shallow breathing index
the ratio of respiratory frequency to tidal volume (f/VT)
Measured: 7 weeks
Oxygenation index.
Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start15 Jun 2018
- Primary completion30 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator DependencyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Yun Chang, Ph.D, Principal investigator, Fooyin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997214
- Sponsor's protocol ID
- 108001
- Acronym
- IMT
- Status last verified
- May 2019
- First submitted
- 4 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Inspiratory Muscle Strength Training on Weaning Parameters Among Ventilator-dependent Patients
- ClinicalTrials.gov ID
- NCT03997214
- Acronym / sponsor ID
- IMT / 108001
- Conditions
- Ventilator Dependency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Jun 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.
The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –as usual care |
| experimental group | Experimental | Device: inspiratory muscle strength trainingThe intervention of inspiratory muscle strength training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age >20y/o
- Vital signs stable
- MIP <20cmH2O
- Ventilator FiO2<40%, PEEP <8
- Ventilator mode:PSV or SIMV
Key exclusion criteria (1 listed)
- Patient or family refuse
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 |
|---|---|---|
| inspiratory muscle strength trainingThe experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly. | Device | experimental group |
Primary outcome
Maximal inspiratory pressure
Time frame: 7 weeks
a measure of the strength of inspiratory muscles, measurement by cmH2O.
Tidal volume
Time frame: 7 weeks
the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration
Minute ventilation volume
Time frame: 7 weeks
the quantity of air moved into and out of the lungs in a minute, measurement by l.min
Rapid shallow breathing index
Time frame: 7 weeks
the ratio of respiratory frequency to tidal volume (f/VT)
Oxygenation index.
Time frame: 7 weeks
Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization
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 25 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Ventilator Dependency
Enrolling by invitationObservational study
Digital Phenotyping of High-Risk Chronic Ventilator-Dependent Patients
Ventilator Dependency
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.
Hsiao-Yun Chang, Ph.D principal investigator
Fooyin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle strength training in people with Ventilator Dependency, run by Fooyin University 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 5 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 25 Jun 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. 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?
Maximal inspiratory pressure (time frame: 7 weeks). The study lists 5 primary outcomes in all. 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 25 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.