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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003053
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : December 13, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critically Ill Respiratory Failure Device: Inspiratory Muscle Trainer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Study Start Date : April 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Inspiratory Muscle Trainer
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.
 Device: Inspiratory Muscle Trainer


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003053


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Peter E Morris, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02003053    
Other Study ID Numbers: IRB00022663
First Posted: December 6, 2013    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: September 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Wake Forest University Health Sciences:
Critically ill
intubated
safety
feasibility
inspiratory muscle training
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Aspiration
Critical Illness
Disease Attributes
 Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases