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Inspiratory Muscle Training in Ventilator Dependent Patients

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status and phase

Completed
Phase 1

Conditions

Respiratory Failure
Ventilator Dependent
Failure to Wean

Treatments

Procedure: inspiratory muscle strength training

Study type

Interventional

Funder types

NIH

Identifiers

NCT00419458
NICHD 5R01HD42705

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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