Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support

NCT01108575 | Completed Phase 1 DMC

• 1 other identifier: UF IRB #723-2009
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.

Conditions

Respiratory Failure

Keywords

Mechanical ventilation; mechanical ventilation weaning; inspiratory muscle strength training; Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation support

  Patients will be observed for up to 28 days following admission to the ICU

Secondary Outcomes (1)

• Maximal inspiratory pressure

  Patients will be observed for up to 28 days following admission to the ICU

Study Arms (2)

Inspiratory muscle strength training

EXPERIMENTAL

Other: IMST

Sham Inspiratory muscle strength training

SHAM COMPARATOR

Other: Sham IMST

Interventions

IMST OTHER

inspiratory muscle strength training

Inspiratory muscle strength training

Sham IMST OTHER

sham inspiratory muscle strength training

Sham Inspiratory muscle strength training

Eligibility Criteria

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

You may qualify if:

• \. Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.

You may not qualify if:

• inability to follow simple, one step commands such as "inspire forcefully",
• patients with prior arrangements to be transferred to other facilities when stabilized,
• any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment,
• unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours,
• use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion,
• severe dysrhythmias,
• acute coronary syndrome
• pulmonary contraindications (pneumon/hemothorax, flail chest),
• acute surgical problems arising in the immediate post operative period (serious postoperative bleeding, wound dehiscence, etc). When and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation.
• active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies)
• spinal cord injuries.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (1)