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Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IMST
Sham IMST
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Mechanical ventilation, mechanical ventilation weaning, inspiratory muscle strength training, Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.

Eligibility Criteria

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

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.

Sites / Locations

  • Shands Hospital at the University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory muscle strength training

Sham Inspiratory muscle strength training

Arm Description

Outcomes

Primary Outcome Measures

Duration of mechanical ventilation support

Secondary Outcome Measures

Maximal inspiratory pressure

Full Information

First Posted
April 20, 2010
Last Updated
December 10, 2013
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01108575
Brief Title
Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support
Official Title
Inspiratory Muscle Strength Training in Ventilator Dependent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Mechanical ventilation, mechanical ventilation weaning, inspiratory muscle strength training, Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle strength training
Arm Type
Experimental
Arm Title
Sham Inspiratory muscle strength training
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
IMST
Intervention Description
inspiratory muscle strength training
Intervention Type
Other
Intervention Name(s)
Sham IMST
Intervention Description
sham inspiratory muscle strength training
Primary Outcome Measure Information:
Title
Duration of mechanical ventilation support
Time Frame
Patients will be observed for up to 28 days following admission to the ICU
Secondary Outcome Measure Information:
Title
Maximal inspiratory pressure
Time Frame
Patients will be observed for up to 28 days following admission to the ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: inability to follow simple, one step commands such as "inspire forcefully", patients with prior arrangements to be transferred to other facilities when stabilized, any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment, unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours, use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion, severe dysrhythmias, acute coronary syndrome pulmonary contraindications (pneumon/hemothorax, flail chest), 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. 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) spinal cord injuries.
Facility Information:
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

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