Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

Phase 1

Completed

• Conditions: Respiratory Failure
• Interventions: Other: IMST; Other: Sham IMST

• Registration Number: NCT01108575
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle strength training	IMST	-
Sham Inspiratory muscle strength training	Sham IMST	-

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation support	Patients will be observed for up to 28 days following admission to the ICU

Secondary Outcome Measures

Name	Time	Method
Maximal inspiratory pressure	Patients will be observed for up to 28 days following admission to the ICU

Trial Locations

Locations (1)

Shands Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States