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Inspiratory Muscle Training in Ventilator Dependent Patients

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00419458
First received: January 4, 2007
Last updated: November 6, 2009
Last verified: November 2009
History of Changes

January 4, 2007
November 6, 2009
February 2004
July 2009   (final data collection date for primary outcome measure)
ventilator dependent status
Same as current
Complete list of historical versions of study NCT00419458 on ClinicalTrials.gov Archive Site
  • breathing patterns during failed and passed unsupported breathing trials
  • maximal inspiratory pressure
Same as current
Not Provided
Not Provided
 
Inspiratory Muscle Training in Ventilator Dependent Patients
Respiratory Muscle Training in Ventilator Dependent Patients

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.

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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Failure to Wean
  • Respiratory Failure
  • Ventilator Dependent
Procedure: inspiratory muscle strength training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00419458
NICHD 5R01HD42705
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Anatole D Martin, Ph D, PT University of Florida
Study Director: Andrea Gabrielli, MD University of Florida
Study Director: Paul Davenport, Ph D University of Florida
Study Director: Joseph Layon, MD University of Florida
Study Director: Maher Baz, MD University of Florida
Study Director: Lawrence Caruso, MD University of Florida
Study Director: Ricardo Gonzalez-Rothi, MD University of Florida
Study Director: Elosie Harman, MD University of Florida
Study Director: Micheal Banner, Ph D University of Florida
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP