Project 4A: Inspiratory Muscle Training and Diaphragm Strength

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially blunt the inflammation and catabolism of Peristent Inflammation/Immunosuppression and Catabolism (PICS).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH)
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• presence in the surgical or trauma ICU

• age of ≥18 years

• received mechanical ventilation (MV) for 3 days and expected to survive ICU stay

• ability to obtain informed consent from patient or proxy

Exclusion Criteria:

• Inability to speak and understand English

• Uncontrollable source of sepsis with imminent death (e.g., irreversible disease state, unresectable dead bowel)

• Receiving "comfort care only" or have advanced care directives limiting resuscitative efforts

• Known HIV infection with CD4 count < 200 cells/mm

• Organ transplant recipients on immunosuppressive agent(s),

• Known pregnancy

• Unable to follow simple, one-step commands, such as "breathe in as hard as you can!"

• Prior arrangements to be transferred to other facilities before 28 days of treatment

• Contraindications to being disconnected from MV for sham or inspiratory muscle strength training treatment

• Unstable or "difficult airway" at 3 days of ICU care defined by ICU protocol, predicted to last for more than 72 hours

• Ongoing use of vasopressor or vasodilatatory agents for unstable blood pressure. (beyond minimal intermittent amount or "renal perfusion dose,"

• Severe cardiac dysrhythmias

• Esophageal varices or recent esophageal or gastric surgery,

• Upper-airway issues that would be aggravated by inserting esophageal pressure transducers

• Unstable neck/cervical anatomy that might be adversely impacted by bilateral magnetic stimulation of phrenic nerves at the neck

• Acute coronary syndrome

• Pulmonary contraindications (pneumon/hemothorax not drained, flail chest)

• Cardiac pacemakers and/or implanted defibrillator or other implanted electronic devices interfering with magnetic stimulation

• Implanted metal in the chest, neck or head, making magnetic stimulation contraindicated (dental fillings are permitted)

• Postoperative severe surgical problems interfering with the respiratory training (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

• 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)

• Any other factor that in the investigators' opinions would prevent response to training or create an unsafe condition for the patient.