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Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Primary Purpose

Chronic Respiratory Failure

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

positive pressure ventilation

About this trial

This is an interventional treatment trial for Chronic Respiratory Failure focused on measuring weaning, work of breathing, spontaneous breathing trial, rapid shallow breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hypercapnic respiratory failure

Exclusion Criteria:

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

Sites / Locations

Kloster GrafschaftRecruiting

Outcomes

Primary Outcome Measures

Endurance time

Secondary Outcome Measures

PCO2, respiratory parameters

Full Information

NCT ID

NCT00415896

First Posted

December 22, 2006

Last Updated

December 22, 2006

Sponsor

Krankenhaus Kloster Grafschaft

1. Study Identification

Unique Protocol Identification Number

NCT00415896

Brief Title

Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Official Title

Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Krankenhaus Kloster Grafschaft

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Respiratory Failure

Keywords

weaning, work of breathing, spontaneous breathing trial, rapid shallow breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

positive pressure ventilation

Primary Outcome Measure Information:

Title

Endurance time

Secondary Outcome Measure Information:

Title

PCO2, respiratory parameters

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hypercapnic respiratory failure Exclusion Criteria: upper Gi pathology renal failure (creatinin > 2 mg/dl) Sepsis or infection age < 18 years

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dominic Dellweg, M.D.

Phone

+49 2972 791

Ext

1257

d.dellweg@fkkg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Dieter Koehler, M.D. Prof.

Phone

+40 2972 791

Ext

2500

d.koehler@fkkg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominic Dellweg, M.D.

Organizational Affiliation

FKKG

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dieter Koehler, M.D., Prof.

Organizational Affiliation

FKKG

Official's Role

Study Chair

Facility Information:

Facility Name

Kloster Grafschaft

City

Schmallenberg

State/Province

Annostr. 1

ZIP/Postal Code

57392

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominic Dellweg, M.D.

Phone

+49 2972 791

Ext

1257

d.dellweg@fkkg.de

First Name & Middle Initial & Last Name & Degree

Dieter Koehler, M.D. Prof.

Phone

+49 2972 791

Ext

2500

d.koehler@fkkg.de

First Name & Middle Initial & Last Name & Degree

Stefan Boeckling

12. IPD Sharing Statement

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