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

NCT02003053 | Completed Results FDA Device

• 1 other identifier: IRB00022663
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill; Respiratory Failure

Keywords

Critically ill; intubated; safety; feasibility; inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

IMT

EXPERIMENTAL

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.

Device: Inspiratory Muscle Trainer

Sham

SHAM COMPARATOR

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.

Device: Inspiratory Muscle Trainer

Interventions

Inspiratory Muscle Trainer DEVICE

IMT; Sham

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known neuromuscular disease
• Unstable cardiac ischemia
• Tracheostomized patients

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Peter Morris
• Organization: University of Kentucky

peter.morris@uky.edu

8593235045

Study Officials

• Peter E Morris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 6, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 7, 2018
• Results First Posted: December 13, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)