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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003053
• Other study ID #: IRB00022663
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Respiratory Aspiration
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Inspiratory Muscle Trainer

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Feasibility of Inspiratory Muscle Training	The number of patients tolerating Inspiratory Muscle Training or Sham.	Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)