Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

This study is currently recruiting participants.
Verified February 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01108575
First received: April 20, 2010
Last updated: February 5, 2013
Last verified: February 2013

April 20, 2010
February 5, 2013
May 2010
December 2013   (final data collection date for primary outcome measure)
Duration of mechanical ventilation support [ Time Frame: Patients will be observed for up to 28 days following admission to the ICU ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01108575 on ClinicalTrials.gov Archive Site
Maximal inspiratory pressure [ Time Frame: Patients will be observed for up to 28 days following admission to the ICU ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support
Inspiratory Muscle Strength Training in Ventilator Dependent Patients

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Respiratory Failure
  • Other: IMST
    inspiratory muscle strength training
  • Other: Sham IMST
    sham inspiratory muscle strength training
  • Experimental: Inspiratory muscle strength training
    Intervention: Other: IMST
  • Sham Comparator: Sham Inspiratory muscle strength training
    Intervention: Other: Sham IMST
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: A. D Martin, PhD, PT 3273-273-6105 dmartin@phhp.ufl.edu
Contact: Andrea Gabrielli, M.D. 352 2650486 AGabrielli@anest.ufl.edu
United States
 
NCT01108575
UF IRB #723-2009
Yes
University of Florida
University of Florida
Not Provided
Not Provided
University of Florida
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP