Clinical trial NCT02367170: Project 4A: Inspiratory Muscle Training and Diaphragm Strength
Official title: Study: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care: Project 4A: Inspiratory Muscle Training and Diaphragm Strength
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Sepsis
Keywords: respiratory dysfunction
chronic critical illness
diaphragm weakness
sepsis
ventilator dependance
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2015-02-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed description: In this research study, investigators will assign study participants to two groups: high intensity inspiratory muscle training and low intensity inspiratory muscle training group. This research study will last up to 28 days in 24 mechanically ventilated patients with CCI. The goal is to determine if the research participants can respond to a training program by improving weaning outcomes from the ventilator. This will be determined by measurement of breathing muscle strength with magnetic stimulation, measurement of diaphragm thickness with ultrasound, inspiratory muscle training, and blood and urine samples.

Eligibility 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.

Primary outcomes:
measure: A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients
timeFrame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28
Secondary outcomes:
measure: A Change in the Results of the Biomarkers of Inflammation From Baseline
timeFrame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21
measure: A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline
timeFrame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Daniel Martin, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
References: