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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Critically Ill Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory Muscle Trainer

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

Inspiratory Muscle Trainer

Intervention Type DEVICE

Interventions

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Inspiratory Muscle Trainer

Intervention Type DEVICE

Eligibility Criteria

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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.