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Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

NCT ID: NCT01108575

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Respiratory Failure

Keywords

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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.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Inspiratory muscle strength training

Group Type EXPERIMENTAL

IMST

Intervention Type OTHER

inspiratory muscle strength training

Sham Inspiratory muscle strength training

Group Type SHAM_COMPARATOR

Sham IMST

Intervention Type OTHER

sham inspiratory muscle strength training

Interventions

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IMST

inspiratory muscle strength training

Intervention Type OTHER

Sham IMST

sham inspiratory muscle strength training

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shands Hospital at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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UF IRB #723-2009

Identifier Type: -

Identifier Source: org_study_id