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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Failure
 Other: IMST
Other: Sham IMST
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Strength Training in Ventilator Dependent Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Maximal inspiratory pressure [ Time Frame: Patients will be observed for up to 28 days following admission to the ICU ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inspiratory muscle strength training Other: IMST
inspiratory muscle strength training
Sham Comparator: Sham Inspiratory muscle strength training Other: Sham IMST
sham inspiratory muscle strength training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108575

Contacts
Contact: A. D Martin, PhD, PT 3273-273-6105 dmartin@phhp.ufl.edu
Contact: Andrea Gabrielli, M.D. 352 2650486 AGabrielli@anest.ufl.edu

Locations
United States, Florida
Shands Hospital at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: A D Martin, PhD, PT            
Principal Investigator: Andrea Gabrielli, M.D.            
Sponsors and Collaborators
University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01108575     History of Changes
Other Study ID Numbers: UF IRB #723-2009
Study First Received: April 20, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
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.

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013