Failure to WeanPhase 1NCT00419458
Inspiratory Muscle Training in Ventilator Dependent Patients
A Phase 1 study testing inspiratory muscle strength training in people with Failure to Wean and Respiratory Failure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Failure to Wean, Respiratory Failure, Ventilator Dependent
- What is being tested?
- inspiratory muscle strength training
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jul 2009
- Phase
- Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital
- medically stable
- able to initiate spontaneous breaths
- able to provide informed consent
- able to follow simple instructions
Who cannot join
- life expectancy < 12 months due to malignancy
- damaged phrenic nerves
- neuromuscular diseases
- heart or lung transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Deprtment of Physical Therapy/Shands Hospital at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Respiratory Muscle Training in Ventilator Dependent Patients
The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.
Read the detailed description
The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.
- Conditions
- Failure to Wean, Respiratory Failure, Ventilator Dependent
- Being tested
- inspiratory muscle strength training
- Keywords
- ventilator weaning, weaning, respiratory failure, inspiratory muscle strength training
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle strength trainingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator dependent status
Secondary outcomes (2)
breathing patterns during failed and passed unsupported breathing trials
maximal inspiratory pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startFeb 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Failure to WeanStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Anatole D Martin, Ph D, PT, Principal investigator, University of FloridaAndrea Gabrielli, MD, Study director, University of FloridaPaul Davenport, Ph D, Study director, University of FloridaJoseph Layon, MD, Study director, University of FloridaMaher Baz, MD, Study director, University of FloridaLawrence Caruso, MD, Study director, University of FloridaRicardo Gonzalez-Rothi, MD, Study director, University of FloridaElosie Harman, MD, Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419458
- Sponsor's protocol ID
- NICHD 5R01HD42705
- Status last verified
- Nov 2009
- First submitted
- 4 Jan 2007
- Last updated
- 9 Nov 2009
- Results posted
- No
Publications
Ozcan MS, Bonett SW, Martin AD, Gabrielli A, Layon AJ, Banner MJ. Abnormally increased power of breathing as a complication of closed endotracheal suction catheter systems. Respir Care. 2006 Apr;51(4):423-5. No abstract available.
PubMed 16569266Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.
PubMed 21385346
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Training in Ventilator Dependent Patients
- ClinicalTrials.gov ID
- NCT00419458
- Acronym / sponsor ID
- NICHD 5R01HD42705
- Conditions
- Failure to Wean, Respiratory Failure, Ventilator Dependent
- Keywords
- ventilator weaning, weaning, respiratory failure, inspiratory muscle strength training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Feb 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Jan 2007 (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.
The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.
Detailed description
The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital
- medically stable
- able to initiate spontaneous breaths
- able to provide informed consent
- able to follow simple instructions
Key exclusion criteria (4 listed)
- life expectancy < 12 months due to malignancy
- damaged phrenic nerves
- neuromuscular diseases
- heart or lung transplant
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 training | Procedure or surgery | – |
Primary outcome
ventilator dependent status
2 secondary outcomes
breathing patterns during failed and passed unsupported breathing trials
maximal inspiratory pressure
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 9 Nov 2009.
- Background: PubMed 16569266Ozcan MS, Bonett SW, Martin AD, Gabrielli A, Layon AJ, Banner MJ. Abnormally increased power of breathing as a complication of closed endotracheal suction catheter systems. Respir Care. 2006 Apr;51(4):423-5. No abstract available.
- Derived from this study: PubMed 21385346Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.
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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.
Anatole D Martin, Ph D, PT principal investigator
University of Florida
Andrea Gabrielli, MD study director
University of Florida
Paul Davenport, Ph D study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing inspiratory muscle strength training in people with Failure to Wean and Respiratory Failure, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 5 inclusion and 4 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 9 Nov 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
ventilator dependent status. 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 NCT00419458, which also lists 2 linked publications.
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 9 Nov 2009.