Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108575
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Other: IMST Other: Sham IMST Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Strength Training in Ventilator Dependent Patients
Study Start Date : May 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Duration of mechanical ventilation support [ Time Frame: Patients will be observed for up to 28 days following admission to the ICU ]

Secondary Outcome Measures :
  1. Maximal inspiratory pressure [ Time Frame: Patients will be observed for up to 28 days following admission to the ICU ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01108575

United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida

Responsible Party: University of Florida Identifier: NCT01108575     History of Changes
Other Study ID Numbers: UF IRB #723-2009
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

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 Insufficiency
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes