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Completed

NCT Number: NCT01108575

Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

IMST

Other

inspiratory muscle strength training

Sham IMST

Other

sham inspiratory muscle strength training

Primary outcomes

  1. Duration of mechanical ventilation support

    Time frame: Patients will be observed for up to 28 days following admission to the ICU

Secondary outcomes

  1. Maximal inspiratory pressure

    Time frame: Patients will be observed for up to 28 days following admission to the ICU

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Inspiratory Muscle Strength Training in Ventilator Dependent Patients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 22, 2010
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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