Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

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

Study Overview

• Status: Unknown
• Conditions: Chronic Respiratory Failure
• Intervention / Treatment: Device: positive pressure ventilation

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.

• Study Type: Interventional
• Enrollment: 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominic Dellweg, M.D.; Phone Number: 1257 +49 2972 791; Email: d.dellweg@fkkg.de
• Study Contact Backup: Name: Dieter Koehler, M.D. Prof.; Phone Number: 2500 +40 2972 791; Email: d.koehler@fkkg.de

Study Locations

• Germany
  • Annostr. 1
    • Schmallenberg, Annostr. 1, Germany, 57392
      • Recruiting
      • Kloster Grafschaft
      • Contact: Dominic Dellweg, M.D.; Phone Number: 1257 +49 2972 791; Email: d.dellweg@fkkg.de
      • Contact: Dieter Koehler, M.D. Prof.; Phone Number: 2500 +49 2972 791; Email: d.koehler@fkkg.de
      • Sub-Investigator: Stefan Boeckling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• hypercapnic respiratory failure

Exclusion Criteria:

• upper Gi pathology
• renal failure (creatinin > 2 mg/dl)
• Sepsis or infection
• age < 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Endurance time

Secondary Outcome Measures

Outcome Measure
PCO2, respiratory parameters

Collaborators and Investigators

• Sponsor: Krankenhaus Kloster Grafschaft
• Investigators: Principal Investigator: Dominic Dellweg, M.D., FKKG; Study Chair: Dieter Koehler, M.D., Prof., FKKG

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Study Completion: June 1, 2007

Study Registration Dates

• First Submitted: December 22, 2006
• First Submitted That Met QC Criteria: December 22, 2006
• First Posted (Estimate): December 25, 2006

Study Record Updates

• Last Update Posted (Estimate): December 25, 2006
• Last Update Submitted That Met QC Criteria: December 22, 2006
• Last Verified: December 1, 2006

More Information

Terms related to this study

• Keywords: weaning; work of breathing; spontaneous breathing trial; rapid shallow breathing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: FKKG3