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

Not Applicable

Completed

• Conditions: Critically Ill; Respiratory Failure
• Interventions: Device: Inspiratory Muscle Trainer

• Registration Number: NCT02003053
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Results First Submitted: 2017-08-08
• Results First Submitted QC: 2017-11-10
• Results First Posted: 2017-12-13
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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Exclusion Criteria

• Known neuromuscular disease
• Unstable cardiac ischemia
• Tracheostomized patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMT	Inspiratory Muscle Trainer	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	Inspiratory Muscle Trainer	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.

Primary Outcome Measures

Name	Time	Method
Safety and Feasibility of Inspiratory Muscle Training	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.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States