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Completed

NCT Number: NCT00419458

Inspiratory Muscle Training in Ventilator Dependent Patients

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.

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Key information

Conditions

Failure to Wean Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Ventilator Dependent

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inspiratory muscle strength training

Procedure

Primary outcomes

  1. ventilator dependent status

Secondary outcomes

  1. breathing patterns during failed and passed unsupported breathing trials

  2. maximal inspiratory pressure

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Respiratory Muscle Training in Ventilator Dependent Patients

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jan 8, 2007
Registry last updated
Nov 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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