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Inspiratory Muscle Training in Ventilator Dependent Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00419458
First Posted: January 8, 2007
Last Update Posted: November 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
Primary Purpose: Treatment
Official Title: Respiratory Muscle Training in Ventilator Dependent Patients

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
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
First Submitted: January 4, 2007
First Posted: January 8, 2007
Last Update Posted: November 9, 2009
Last Verified: November 2009

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