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Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Krankenhaus Kloster Grafschaft.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00415896
First Posted: December 25, 2006
Last Update Posted: December 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Krankenhaus Kloster Grafschaft
  Purpose
This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials

Condition Intervention
Chronic Respiratory Failure Device: positive pressure ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Further study details as provided by Krankenhaus Kloster Grafschaft:

Primary Outcome Measures:
  • Endurance time

Secondary Outcome Measures:
  • PCO2, respiratory parameters

Estimated Enrollment: 10
Study Start Date: December 2006
Estimated Study Completion Date: June 2007
Detailed Description:

Liberation from mechanical ventilation in difficult to wean patients is best accomplished by intermittent spontaneous breathing trials (1). Optimal respiratory muscle rest in-between breathing trials however has never been investigated.

Using a crossover design, patients are to be ventilated with complete and partial respiratory muscle unloading for a period of ten hours respectively. Respiratory muscle activity is being monitored by oesophageal balloon technique using a commercially available System (Avea, Viasys, Conshohocken, PA, USA). Time of spontaneous breathing, respiratory- and ABG parameters are being determined to characterize the course of each spontaneous breathing trial.

References

1. Esteban, A., F. Frutos, M. J. Tobin, I. Alia, J. F. Solsona, I. Valverdu, R. Fernandez, M. A. de la Cal, S. Benito, R. Tomas, and et al. 1995. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 332(6):345-50.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypercapnic respiratory failure

Exclusion Criteria:

  • upper Gi pathology
  • renal failure (creatinin > 2 mg/dl)
  • Sepsis or infection
  • age < 18 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415896


Contacts
Contact: Dominic Dellweg, M.D. +49 2972 791 ext 1257 d.dellweg@fkkg.de
Contact: Dieter Koehler, M.D. Prof. +40 2972 791 ext 2500 d.koehler@fkkg.de

Locations
Germany
Kloster Grafschaft Recruiting
Schmallenberg, Annostr. 1, Germany, 57392
Contact: Dominic Dellweg, M.D.    +49 2972 791 ext 1257    d.dellweg@fkkg.de   
Contact: Dieter Koehler, M.D. Prof.    +49 2972 791 ext 2500    d.koehler@fkkg.de   
Sub-Investigator: Stefan Boeckling         
Sponsors and Collaborators
Krankenhaus Kloster Grafschaft
Investigators
Principal Investigator: Dominic Dellweg, M.D. FKKG
Study Chair: Dieter Koehler, M.D., Prof. FKKG
  More Information

ClinicalTrials.gov Identifier: NCT00415896     History of Changes
Other Study ID Numbers: FKKG3
First Submitted: December 22, 2006
First Posted: December 25, 2006
Last Update Posted: December 25, 2006
Last Verified: December 2006

Keywords provided by Krankenhaus Kloster Grafschaft:
weaning
work of breathing
spontaneous breathing trial
rapid shallow breathing

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases