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Inspiratory Muscle Training in Ventilator Dependent Patients

Respiratory Muscle Training in Ventilator Dependent Patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00419458
Enrollment
150
Registered
2007-01-08
Start date
2004-02-29
Completion date
2009-07-31
Last updated
2009-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failure to Wean, Respiratory Failure, Ventilator Dependent

Keywords

ventilator weaning, weaning, respiratory failure, inspiratory muscle strength training

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.

Interventions

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ventilator dependent status

Secondary

MeasureTime frame
breathing patterns during failed and passed unsupported breathing trials
maximal inspiratory pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026