Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

Respiratory Failure Clinical Trial

Official title:

Inspiratory Muscle Strength Training in Ventilator Dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108575
• Other study ID #: UF IRB #723-2009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 20, 2010
• Last updated: December 10, 2013
• Start date: May 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• IMST
inspiratory muscle strength training
• Sham IMST
sham inspiratory muscle strength training

Locations

Country	Name	City	State
United States	Shands Hospital at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation support		Patients will be observed for up to 28 days following admission to the ICU	Yes
Secondary	Maximal inspiratory pressure		Patients will be observed for up to 28 days following admission to the ICU	No