Inspiratory Muscle Training in Ventilator Dependent Patients

• ClinicalTrials.gov Identifier: NCT00419458
• Recruitment Status: Completed
• First Posted: January 8, 2007
• Last Update Posted: November 9, 2009
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Failure to Wean; Respiratory Failure; Ventilator Dependent	Procedure: inspiratory muscle strength training	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Respiratory Muscle Training in Ventilator Dependent Patients
• Study Start Date: February 2004
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. ventilator dependent status

Secondary Outcome Measures :

1. breathing patterns during failed and passed unsupported breathing trials
2. maximal inspiratory pressure

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• 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

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

Publications:

Ozcan MS, Bonett SW, Martin AD, Gabrielli A, Layon AJ, Banner MJ. Abnormally increased power of breathing as a complication of closed endotracheal suction catheter systems. Respir Care. 2006 Apr;51(4):423-5.

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

Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.

• ClinicalTrials.gov Identifier: NCT00419458
• Other Study ID Numbers: NICHD 5R01HD42705
• 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