Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

NCT ID: NCT00415896

Last Updated: 2006-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Respiratory Failure

Keywords

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weaning work of breathing spontaneous breathing trial rapid shallow breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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positive pressure ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* hypercapnic respiratory failure

Exclusion Criteria

* upper Gi pathology
* renal failure (creatinin \> 2 mg/dl)
* Sepsis or infection
* age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Kloster Grafschaft

OTHER

Sponsor Role lead

Principal Investigators

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Dominic Dellweg, M.D.

Role: PRINCIPAL_INVESTIGATOR

FKKG

Dieter Koehler, M.D., Prof.

Role: STUDY_CHAIR

FKKG

Locations

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Kloster Grafschaft

Schmallenberg, Annostr. 1, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dominic Dellweg, M.D.

Role: CONTACT

Phone: +49 2972 791

Email: [email protected]

Dieter Koehler, M.D. Prof.

Role: CONTACT

Phone: +40 2972 791

Email: [email protected]

Facility Contacts

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Dominic Dellweg, M.D.

Role: primary

Dieter Koehler, M.D. Prof.

Role: backup

Other Identifiers

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FKKG3

Identifier Type: -

Identifier Source: org_study_id