Critically Ill, Respiratory Failure
Conditions
Keywords
Critically ill, intubated, safety, feasibility, inspiratory muscle training
Brief summary
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.
Interventions
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Mechanically ventilated patients. * Must have passed spontaneuos brething trial screening but failed the trial itself. * Potential subject must be able to perform atleast 5 minutes of spontaneous breathing trial.
Exclusion criteria
* Known neuromuscular disease * Unstable cardiac ischemia * Tracheostomized patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Feasibility of Inspiratory Muscle Training | Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline) | The number of patients tolerating Inspiratory Muscle Training or Sham. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Sham | Total | Inpsiratory Muscle Training |
|---|---|---|---|
| Age, Continuous | 54.33 years STANDARD_DEVIATION 3.78 | 51.29 years STANDARD_DEVIATION 11.28 | 49.0 years STANDARD_DEVIATION 16.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 7 participants | 4 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Safety and Feasibility of Inspiratory Muscle Training
The number of patients tolerating Inspiratory Muscle Training or Sham.
Time frame: Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inspiratory Muscle Training | Safety and Feasibility of Inspiratory Muscle Training | 3 Participants |
| Sham | Safety and Feasibility of Inspiratory Muscle Training | 3 Participants |