NCT00419458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

5.4 years

First QC Date

January 4, 2007

Last Update Submit

November 6, 2009

Conditions

Failure to WeanRespiratory FailureVentilator Dependent

Keywords

ventilator weaningweaningrespiratory failureinspiratory muscle strength training

Outcome Measures

Primary Outcomes (1)

  • ventilator dependent status

Secondary Outcomes (2)

  • breathing patterns during failed and passed unsupported breathing trials

  • maximal inspiratory pressure

Interventions

inspiratory muscle strength trainingPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

  • 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.

    PMID: 16569266BACKGROUND

  • 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.

    PMID: 21385346DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Anatole D Martin, Ph D, PT

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Andrea Gabrielli, MD

    University of Florida

    STUDY DIRECTOR

  • Paul Davenport, Ph D

    University of Florida

    STUDY DIRECTOR

  • Joseph Layon, MD

    University of Florida

    STUDY DIRECTOR

  • Maher Baz, MD

    University of Florida

    STUDY DIRECTOR

  • Lawrence Caruso, MD

    University of Florida

    STUDY DIRECTOR

  • Ricardo Gonzalez-Rothi, MD

    University of Florida

    STUDY DIRECTOR

  • Elosie Harman, MD

    University of Florida

    STUDY DIRECTOR

  • Micheal Banner, Ph D

    University of Florida

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

February 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

US(1)