Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

December 10, 2013 updated by: University of Florida

Inspiratory Muscle Strength Training in Ventilator Dependent Patients

A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • 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
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.

Exclusion Criteria:

  1. inability to follow simple, one step commands such as "inspire forcefully",
  2. patients with prior arrangements to be transferred to other facilities when stabilized,
  3. any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment,
  4. unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours,
  5. use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion,
  6. severe dysrhythmias,
  7. acute coronary syndrome
  8. pulmonary contraindications (pneumon/hemothorax, flail chest),
  9. acute surgical problems arising in the immediate post operative period (serious postoperative bleeding, wound dehiscence, etc). When and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation.
  10. active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies)
  11. spinal cord injuries.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory muscle strength training
Other: IMST
inspiratory muscle strength training
Sham Comparator: Sham Inspiratory muscle strength training
Other: Sham IMST
sham inspiratory muscle strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of mechanical ventilation support
Time Frame: Patients will be observed for up to 28 days following admission to the ICU
Patients will be observed for up to 28 days following admission to the ICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal inspiratory pressure
Time Frame: Patients will be observed for up to 28 days following admission to the ICU
Patients will be observed for up to 28 days following admission to the ICU

Collaborators and Investigators

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

Sponsor

University of Florida

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

May 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF IRB #723-2009

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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