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Inspiratory Muscle Training in Ventilator Dependent Patients

Primary Purpose

Failure to Wean, Respiratory Failure, Ventilator Dependent

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
inspiratory muscle strength training
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failure to Wean focused on measuring ventilator weaning, weaning, respiratory failure, inspiratory muscle strength training

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deprtment of Physical Therapy/Shands Hospital at the University of Florida

Outcomes

Primary Outcome Measures

ventilator dependent status

Secondary Outcome Measures

breathing patterns during failed and passed unsupported breathing trials
maximal inspiratory pressure

Full Information

First Posted
January 4, 2007
Last Updated
November 6, 2009
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00419458
Brief Title
Inspiratory Muscle Training in Ventilator Dependent Patients
Official Title
Respiratory Muscle Training in Ventilator Dependent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Wean, Respiratory Failure, Ventilator Dependent
Keywords
ventilator weaning, weaning, respiratory failure, inspiratory muscle strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
inspiratory muscle strength training
Primary Outcome Measure Information:
Title
ventilator dependent status
Secondary Outcome Measure Information:
Title
breathing patterns during failed and passed unsupported breathing trials
Title
maximal inspiratory pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anatole D Martin, Ph D, PT
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Gabrielli, MD
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Davenport, Ph D
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joseph Layon, MD
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maher Baz, MD
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lawrence Caruso, MD
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ricardo Gonzalez-Rothi, MD
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elosie Harman, MD
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Micheal Banner, Ph D
Organizational Affiliation
University of Florida
Official's Role
Study Director
Facility Information:
Facility Name
Deprtment of Physical Therapy/Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16569266
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
21385346
Citation
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.
Results Reference
derived

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Inspiratory Muscle Training in Ventilator Dependent Patients

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