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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
  Purpose

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.


Condition Intervention Phase
Failure to Wean
Respiratory Failure
Ventilator Dependent
 Procedure: inspiratory muscle strength training
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Respiratory Muscle Training in Ventilator Dependent Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • ventilator dependent status

Secondary Outcome Measures:
  • breathing patterns during failed and passed unsupported breathing trials
  • maximal inspiratory pressure

Estimated Enrollment: 150
Study Start Date: February 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419458

Locations
United States, Florida
Deprtment of Physical Therapy/Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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
  More Information

Additional Information:
Home page for the Department of Physical Therapy at the University of Florida  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00419458     History of Changes
Other Study ID Numbers: NICHD 5R01HD42705
Study First Received: January 4, 2007
Last Updated: November 6, 2009
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
ventilator weaning
weaning
respiratory failure
inspiratory muscle strength training

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013