Respiratory Failure
Conditions
Keywords
Mechanical ventilation, mechanical ventilation weaning, inspiratory muscle strength training, Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.
Brief summary
A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.
Interventions
OTHERIMST
inspiratory muscle strength training
OTHERSham IMST
sham inspiratory muscle strength training
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.
Exclusion criteria
1. inability to follow simple, one step commands such as inspire forcefully, 2. patients with prior arrangements to be transferred to other facilities when stabilized, 3. any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment, 4. unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours, 5. use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion, 6. severe dysrhythmias, 7. acute coronary syndrome 8. pulmonary contraindications (pneumon/hemothorax, flail chest), 9. acute surgical problems arising in the immediate post operative period (serious postoperative bleeding, wound dehiscence, etc). When and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation. 10. active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies) 11. spinal cord injuries.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation support | Patients will be observed for up to 28 days following admission to the ICU |
Secondary
| Measure | Time frame |
|---|---|
| Maximal inspiratory pressure | Patients will be observed for up to 28 days following admission to the ICU |
Countries
United States
Outcome results
None listed