Respiratory FailurePhase 1/2NCT01108575
Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support
A Phase 1/2 study testing IMST in people with Respiratory Failure, run by University of Florida at 1 site in United States.
Trial summary
A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- IMST
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2013
- Phase
- Phase 1/2
- 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
- 1. Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.
Who cannot join
- inability to follow simple, one step commands such as "inspire forcefully",
- patients with prior arrangements to be transferred to other facilities when stabilized,
- any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment,
- unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours,
- use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion,
- severe dysrhythmias,
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- acute coronary syndrome
- pulmonary contraindications (pneumon/hemothorax, flail chest),
- acute surgical problems arising in the immediate post operative period (serious postoperative bleeding, wound dehiscence, etc). When and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation.
- active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies)
- spinal cord injuries.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Inspiratory Muscle Strength Training in Ventilator Dependent Patients
A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.
- Conditions
- Respiratory Failure
- Being tested
- IMST, Sham IMST
- Keywords
- Mechanical ventilation, mechanical ventilation weaning, inspiratory muscle strength training, Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMSTOther
inspiratory muscle strength training
Sham IMSTOther
sham inspiratory muscle strength training
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle strength training | Experimental | Not described Receives: Other: IMST |
| Sham Inspiratory muscle strength training | Sham comparator | Not described Receives: Other: Sham IMST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation support
Measured: Patients will be observed for up to 28 days following admission to the ICU
Secondary outcomes (1)
Maximal inspiratory pressure
Measured: Patients will be observed for up to 28 days following admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108575
- Sponsor's protocol ID
- UF IRB #723-2009
- Status last verified
- Dec 2013
- First submitted
- 20 Apr 2010
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Strength Training in Ventilator Dependent Patients
- ClinicalTrials.gov ID
- NCT01108575
- Acronym / sponsor ID
- UF IRB #723-2009
- Conditions
- Respiratory Failure
- Keywords
- Mechanical ventilation, mechanical ventilation weaning, inspiratory muscle strength training, Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Apr 2010 (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.
A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle strength training | Experimental | Other: IMST |
| Sham Inspiratory muscle strength training | Sham comparator | Other: Sham IMST |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.
Key exclusion criteria (11 listed)
- inability to follow simple, one step commands such as "inspire forcefully",
- patients with prior arrangements to be transferred to other facilities when stabilized,
- any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment,
- unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours,
- use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion,
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 |
|---|---|---|
| IMSTinspiratory muscle strength training | Other | Inspiratory muscle strength training |
| Sham IMSTsham inspiratory muscle strength training | Other | Sham Inspiratory muscle strength training |
Primary outcome
Duration of mechanical ventilation support
Time frame: Patients will be observed for up to 28 days following admission to the ICU
1 secondary outcome
Maximal inspiratory pressure
Time frame: Patients will be observed for up to 28 days following admission to the ICU
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 11 Dec 2013.
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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 Phase 1/2 study testing IMST in people with Respiratory Failure, run by University of Florida at 1 site in United States.
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 11 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 11 Dec 2013. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of mechanical ventilation support (time frame: Patients will be observed for up to 28 days following admission to the ICU). 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 11 Dec 2013.