WeaningPhase 4IMTNCT00922493
Inspiratory Muscle Training in Weaning
A Phase 4 study testing inspiratory muscle training in people with Weaning, run by Euro-American Network of Human Kinetics at 1 site in Brazil.
Trial summary
Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Weaning
- What is being tested?
- inspiratory muscle training
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Dec 2007to Nov 2008
- Phase
- Phase 4
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the individuals of the sample were required to have undergone Mechanical Ventilation for at least 48 hours in a controlled way
- intubation is diagnostic for acute respiratory injury type 1
- has a maximum value of MIP of -20 cmH2O16
Who cannot join
- any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy).
- Tracheostomized patients (in the pre-test).
- patients with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma.
- patients with morbid obesity
- patients taking medicine that could cause a disorder of attention.
- cases of auto-extubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training
Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success.
Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.
Read the detailed description
The sample for this investigation was selected in a randomized way in the period between December 2007 and November 2008. The individuals were successively entered in the research as they were admitted to the ICU, in respect of the criteria of inclusion and exclusion. From the total number of admitted patients in the period (n=67), many were excluded because they had been tracheostomized (n=25), were dead (n=13) or were transferred out of the hospital (n=1). Those that remained intubated (n=28) and went to the spontaneous mode were chosen randomly and in alternating fashion were divided into the experimental group (EG) or the control group (CG). The EG (n=14; age=82±4 years-old) underwent conventional physiotherapy plus inspiratory muscular training with threshold IMT® (Respironics/EUA - 2004), and the CG (n=14; age=81±6 years-old) received only conventional physiotherapy with no intervention that favored the inspiratory muscle strengthening.
As inclusion criteria, the individuals of the sample were required to have undergone MV for at least 48 hours in a controlled way13, as intubation is diagnostic for acute respiratory injury type 1 and has a maximum value of MIP of -20 cmH2O16.
Exclusion criteria included any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease17, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy). Tracheostomized patients (in the pre-test), those with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma), those with morbid obesity or those taking medicine that could cause a disorder of attention, as well as cases of auto-extubation, were also excluded.
The criteria of inclusion and exclusion were evaluated via examination of the patients' medical records and physical examination daily and in each session. The daily adherence of the patients to the necessary parameters for the study was noted for each patient.
- Conditions
- Weaning
- Being tested
- inspiratory muscle training
- Keywords
- weaning, inspiratory muscle training, maximum inspiratory pressure (MIP), index of Tobin (IT), intubated, intensive care unit, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
Protocol of inspiratory muscle training using threshold IMT®: After the MIP was measured, inspiratory muscle training was initiated. The Threshold-IMT® device of a linear pressure load produces a resistance to inspiration through the use of a flow-independent one-way valve. During expiration there is no resistance because the unidirectional valve opens, while during inspiration the valve closes, becoming "hard" due to the resistance of the spring. The suggested protocol was: initial load of 30% of the M24, increasing daily by 10%, with training for five minutes, twice a day, seven times a week in the period from the beginning of the weaning from the MV until the extubation of the patient.
An essential factor was the use of supplemental oxygen (O2) as needed by the patient. The patients were in DD with fowler 45º.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the MIP
Secondary outcomes (1)
Measurement of rapid shallow breathing (IT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startDec 2007
- Study completionNov 2008
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 WeaningStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Euro-American Network of Human Kinetics
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922493
- Sponsor's protocol ID
- 250525
- Acronym
- IMT
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cader SA, Vale RG, Castro JC, Bacelar SC, Biehl C, Gomes MC, Cabrer WE, Dantas EH. Inspiratory muscle training improves maximal inspiratory pressure and may assist weaning in older intubated patients: a randomised trial. J Physiother. 2010;56(3):171-7. doi: 10.1016/s1836-9553(10)70022-9.
PubMed 20795923
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning Process in Elderly Intubated Patients Submitted to Inspiratory Muscle Training
- ClinicalTrials.gov ID
- NCT00922493
- Acronym / sponsor ID
- IMT / 250525
- Conditions
- Weaning
- Keywords
- weaning, inspiratory muscle training, maximum inspiratory pressure (MIP), index of Tobin (IT), intubated, intensive care unit, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Euro-American Network of Human KineticsUniversity, hospital or other
- Study start
- Dec 2007
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Jun 2009 (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.
Background: the objective of the present inquiry was to evaluate the weaning process in intubated older people subjected to inspiratory muscle training and to correlate the predictors of ventilatory interruption with its success.
Methods: the patients were divided randomly into an experimental group (EG, n=14; age=82±4 years) that received conventional physiotherapy plus inspiratory muscle training (IMT) with threshold IMT® and a control group (CG, n=14; age=81±6 years) that received only conventional physiotherapy. The predictors evaluates were the maximum inspiratory pressure (MIP) and the index of Tobin (IT). The protocol for muscle training consisted of an initial load of 30% MIP, which was increased by 10% daily; training was administered for five minutes, twice a day, seven times a week with supplemental oxygen for the entire period from the decision to wean up to extubation.
Detailed description
The sample for this investigation was selected in a randomized way in the period between December 2007 and November 2008. The individuals were successively entered in the research as they were admitted to the ICU, in respect of the criteria of inclusion and exclusion. From the total number of admitted patients in the period (n=67), many were excluded because they had been tracheostomized (n=25), were dead (n=13) or were transferred out of the hospital (n=1). Those that remained intubated (n=28) and went to the spontaneous mode were chosen randomly and in alternating fashion were divided into the experimental group (EG) or the control group (CG). The EG (n=14; age=82±4 years-old) underwent conventional physiotherapy plus inspiratory muscular training with threshold IMT® (Respironics/EUA - 2004), and the CG (n=14; age=81±6 years-old) received only conventional physiotherapy with no intervention that favored the inspiratory muscle strengthening.
As inclusion criteria, the individuals of the sample were required to have undergone MV for at least 48 hours in a controlled way13, as intubation is diagnostic for acute respiratory injury type 1 and has a maximum value of MIP of -20 cmH2O16.
Exclusion criteria included any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease17, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy). Tracheostomized patients (in the pre-test), those with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma), those with morbid obesity or those taking medicine that could cause a disorder of attention, as well as cases of auto-extubation, were also excluded.
The criteria of inclusion and exclusion were evaluated via examination of the patients' medical records and physical examination daily and in each session. The daily adherence of the patients to the necessary parameters for the study was noted for each patient.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the individuals of the sample were required to have undergone Mechanical Ventilation for at least 48 hours in a controlled way
- intubation is diagnostic for acute respiratory injury type 1
- has a maximum value of MIP of -20 cmH2O16
Key exclusion criteria (6 listed)
- any type of acute condition (cardiac arrhythmia) or chronic condition, such as insufficient congestive heart failure or unstable ischemic cardiac disease, that could compromise weaning or could impede the accomplishment of inspiratory muscle training (neuropathy and myopathy).
- Tracheostomized patients (in the pre-test).
- patients with neurological problems (cerebral vascular accident, cerebrospinal trauma or spinal medullar trauma.
- patients with morbid obesity
- patients taking medicine that could cause a disorder of attention.
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 trainingProtocol of inspiratory muscle training using threshold IMT®: After the MIP was measured, inspiratory muscle training was initiated. The Threshold-IMT® device of a linear pressure load produces a resistance to inspiration through the use of a flow-independent one-way valve. During expiration there is no resistance because the unidirectional valve opens, while during inspiration the valve closes, becoming "hard" due to the resistance of the spring. The suggested protocol was: initial load of 30% of the M24, increasing daily by 10%, with training for five minutes, twice a day, seven times a week in the period from the beginning of the weaning from the MV until the extubation of the patient. An essential factor was the use of supplemental oxygen (O2) as needed by the patient. The patients were in DD with fowler 45º. | Other | – |
Primary outcome
Measurement of the MIP
1 secondary outcome
Measurement of rapid shallow breathing (IT)
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 18 Jun 2009.
- Derived from this study: PubMed 20795923Cader SA, Vale RG, Castro JC, Bacelar SC, Biehl C, Gomes MC, Cabrer WE, Dantas EH. Inspiratory muscle training improves maximal inspiratory pressure and may assist weaning in older intubated patients: a randomised trial. J Physiother. 2010;56(3):171-7. doi: 10.1016/s1836-9553(10)70022-9.
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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 4 study testing inspiratory muscle training in people with Weaning, run by Euro-American Network of Human Kinetics at 1 site in Brazil.
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 3 inclusion and 6 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 18 Jun 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Measurement of the MIP. 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 NCT00922493, 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 18 Jun 2009.