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Inspiratory Muscle Training in Ventilator Dependent Patients

Phase 1
Completed
Conditions
Failure to Wean
Respiratory Failure
Ventilator Dependent
Registration Number
NCT00419458
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brief Summary

The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.

Detailed Description

The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital
  • medically stable
  • able to initiate spontaneous breaths
  • able to provide informed consent
  • able to follow simple instructions
Exclusion Criteria
  • life expectancy < 12 months due to malignancy
  • damaged phrenic nerves
  • neuromuscular diseases
  • heart or lung transplant

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
ventilator dependent status
Secondary Outcome Measures
NameTimeMethod
breathing patterns during failed and passed unsupported breathing trials
maximal inspiratory pressure

Trial Locations

Locations (1)

Deprtment of Physical Therapy/Shands Hospital at the University of Florida

🇺🇸

Gainesville, Florida, United States

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