Clinical trial NCT00419458: Inspiratory Muscle Training in Ventilator Dependent Patients
Official title: Respiratory Muscle Training in Ventilator Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Failure to Wean
Respiratory Failure
Ventilator Dependent
Keywords: ventilator weaning
weaning
respiratory failure
inspiratory muscle strength training
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.

Detailed description: The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.

Eligibility criteria: Inclusion Criteria:

* Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital
* medically stable
* able to initiate spontaneous breaths
* able to provide informed consent
* able to follow simple instructions

Exclusion Criteria:

* life expectancy \< 12 months due to malignancy
* damaged phrenic nerves
* neuromuscular diseases
* heart or lung transplant

Primary outcomes:
measure: ventilator dependent status
Secondary outcomes:
measure: breathing patterns during failed and passed unsupported breathing trials
measure: maximal inspiratory pressure
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Deprtment of Physical Therapy/Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Anatole D Martin, Ph D, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Andrea Gabrielli, MD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Paul Davenport, Ph D
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Joseph Layon, MD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Maher Baz, MD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Lawrence Caruso, MD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Ricardo Gonzalez-Rothi, MD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Elosie Harman, MD
role: STUDY_DIRECTOR
affiliation: University of Florida
name: Micheal Banner, Ph D
role: STUDY_DIRECTOR
References:
citation: Ozcan MS, Bonett SW, Martin AD, Gabrielli A, Layon AJ, Banner MJ. Abnormally increased power of breathing as a complication of closed endotracheal suction catheter systems. Respir Care. 2006 Apr;51(4):423-5. No abstract available.
citation: Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.