A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Safety and Feasibility of Inspiratory Muscle Training
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
IMT
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.
Intervention: Inspiratory Muscle Trainer (Device)
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.
Intervention: Inspiratory Muscle Trainer (Device)
Outcomes
Primary Outcomes
Safety and Feasibility of Inspiratory Muscle Training
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported