Inspiratory Muscle Training in Ventilator Dependent Patients

Respiratory Failure Clinical Trial

Official title:

Respiratory Muscle Training in Ventilator Dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419458
• Other study ID #: NICHD 5R01HD42705
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2007
• Last updated: November 6, 2009
• Start date: February 2004
• Est. completion date: July 2009

Study information

• Verified date: November 2009
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failure to Wean
• Respiratory Failure
• Respiratory Insufficiency
• Ventilator Dependent

Intervention

Procedure:
• inspiratory muscle strength training

Locations

Country	Name	City	State
United States	Deprtment of Physical Therapy/Shands Hospital at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilator dependent status
Secondary	breathing patterns during failed and passed unsupported breathing trials
Secondary	maximal inspiratory pressure

External Links

•   Home page for the Department of Physical Therapy at the University of Florida