Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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, Annostr. 1
	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

Study ID Numbers:	FKKG3
First Received:	December 22, 2006
Last Updated:	December 22, 2006
ClinicalTrials.gov Identifier:	NCT00415896
Health Authority:	Germany: Ethics Commission

Keywords provided by Krankenhaus Kloster Grafschaft:

weaning

work of breathing

spontaneous breathing trial

rapid shallow breathing

Study placed in the following topic categories:

Respiratory Insufficiency

Respiratory Tract Diseases

Respiration Disorders

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Krankenhaus Kloster Grafschaft
Information provided by:	Krankenhaus Kloster Grafschaft
ClinicalTrials.gov Identifier:	NCT00415896