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

Wake Forest University (WFU)

Status: Completed

Conditions: Respiratory Failure; Critically Ill

Treatments: Device: Inspiratory Muscle Trainer

Study type: Interventional

Funder types: Other

Identifiers

NCT02003053

IRB00022663

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7 participants in 2 patient groups

IMT

Experimental group

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.

Treatment:

Device: Inspiratory Muscle Trainer

Sham

Sham Comparator group

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.

Treatment:

Device: Inspiratory Muscle Trainer