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Completed

NCT Number: NCT02003053

A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU

Inspiratory muscle training (IMT) is an intervention used with success in the outpatient setting within the COPD population. Use of IMT is also theoretically possible during mechanical ventilation. This study will will assess the feasibility and safety of the study of IMT in the patient population.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mechanically ventilated patients.
  • Must have passed spontaneuos brething trial screening but failed the trial itself.
  • Potential subject must be able to perform atleast 5 minutes of spontaneous breathing trial.

Exclusion criteria

  • Known neuromuscular disease
  • Unstable cardiac ischemia
  • Tracheostomized patients

Treatment and study plan

Inspiratory Muscle Trainer

Device

Primary outcomes

  1. Safety and Feasibility of Inspiratory Muscle Training

    Time frame: Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)

    The number of patients tolerating Inspiratory Muscle Training or Sham.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
Sep 7, 2018

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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