Back to resultsA Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Primary Purpose
Critically Ill, Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Muscle Trainer
Sponsored by
About this trial
This is an interventional other trial for Critically Ill focused on measuring Critically ill, intubated, safety, feasibility, inspiratory muscle training
Eligibility 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
Sites / Locations
- Wake Forest Baptist Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
IMT
Sham
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Safety and Feasibility of Inspiratory Muscle Training
The number of patients tolerating Inspiratory Muscle Training or Sham.
Secondary Outcome Measures
Full Information
NCT ID
NCT02003053
First Posted
November 21, 2013
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02003053
Brief Title
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Official Title
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Respiratory Failure
Keywords
Critically ill, intubated, safety, feasibility, inspiratory muscle training
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Trainer
Primary Outcome Measure Information:
Title
Safety and Feasibility of Inspiratory Muscle Training
Description
The number of patients tolerating Inspiratory Muscle Training or Sham.
Time Frame
Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E Morris, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
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