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NCT00415896 Clinical Trial

Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Chronic Respiratory Failure Clinical Trial

Official title:
Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00415896
Other study ID # FKKG3
Secondary ID
Status Recruiting
Phase N/A
First received December 22, 2006
Last updated December 22, 2006
Start date December 2006
Est. completion date June 2007

Study information
Verified date December 2006
Source Krankenhaus Kloster Grafschaft
Contact Dominic Dellweg, M.D.
Phone +49 2972 791
Email d.dellweg@fkkg.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- hypercapnic respiratory failure

Exclusion Criteria:

- upper Gi pathology

- renal failure (creatinin > 2 mg/dl)

- Sepsis or infection

- age < 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• positive pressure ventilation

Locations
Country Name City State
Germany Kloster Grafschaft Schmallenberg Annostr. 1

Sponsors (1)
Lead Sponsor Collaborator
Krankenhaus Kloster Grafschaft

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endurance time
Secondary PCO2, respiratory parameters
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