Inspiratory Muscle Training in Ventilator Dependent Patients

November 6, 2009 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Respiratory Muscle Training in Ventilator Dependent Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Deprtment of Physical Therapy/Shands Hospital at the University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ventilator dependent status

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

November 9, 2009

Last Update Submitted That Met QC Criteria

November 6, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICHD 5R01HD42705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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