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Inspiratory muscle training (IMT) is an intervention used with success in the outpatient setting within the COPD population. Use of IMT is also theoretically possible during mechanical ventilation. This study will will assess the feasibility and safety of the study of IMT in the patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMT | Experimental | In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. |
|
| Sham | Sham Comparator | In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Trainer | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Feasibility of Inspiratory Muscle Training | The number of patients tolerating Inspiratory Muscle Training or Sham. | Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter E Morris, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspiratory Muscle Training | In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer |
| FG001 | Sham | In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inpsiratory Muscle Training | In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Feasibility of Inspiratory Muscle Training | The number of patients tolerating Inspiratory Muscle Training or Sham. | Posted | Count of Participants | Participants | Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline) |
|
Adverse events were collected for each patient from the time of enrollment in the study until the patient was either extubated or discharged from the critical care unit, whichever occurred first (up to 1 month post-baseline).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inspiratory Muscle Training Group | In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Morris | University of Kentucky | 8593235045 | peter.morris@uky.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| BG001 | Sham | In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.
Inspiratory Muscle Trainer
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Sham Group | In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge. Inspiratory Muscle Trainer | 0 | 3 | 0 | 3 |
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| D012140 | Respiratory Tract Diseases |