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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2015

Interventions

  • Device: Inspiratory Muscle Trainer

Arms, Groups and Cohorts

  • Experimental: IMT
    • In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.
  • Sham Comparator: Sham
    • In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter E Morris, MD, Principal Investigator, Wake Forest University Health Sciences

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