Inspiratory Muscle Training in Ventilator Dependent Patients

NCT ID: NCT00419458

Last Updated: 2009-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Failure to Wean Respiratory Failure Ventilator Dependent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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inspiratory muscle strength training

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Principal Investigators

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Anatole D Martin, Ph D, PT

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Andrea Gabrielli, MD

Role: STUDY_DIRECTOR

University of Florida

Paul Davenport, Ph D

Role: STUDY_DIRECTOR

University of Florida

Joseph Layon, MD

Role: STUDY_DIRECTOR

University of Florida

Maher Baz, MD

Role: STUDY_DIRECTOR

University of Florida

Lawrence Caruso, MD

Role: STUDY_DIRECTOR

University of Florida

Ricardo Gonzalez-Rothi, MD

Role: STUDY_DIRECTOR

University of Florida

Elosie Harman, MD

Role: STUDY_DIRECTOR

University of Florida

Micheal Banner, Ph D

Role: STUDY_DIRECTOR

University of Florida

Locations

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Deprtment of Physical Therapy/Shands Hospital at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16569266 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21385346 (View on PubMed)

Other Identifiers

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NICHD 5R01HD42705

Identifier Type: -

Identifier Source: org_study_id

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