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Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode

Primary Purpose

Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
non-invasive ventilation
Sponsored by
Krankenhaus Kloster Grafschaft
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring work of breathing, pressure time product, muscle pressures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy voluntary individuals PFT within normal limits Exclusion Criteria: Disease of the upper GI-tract Any form of lung disease or disease of the upper airways Any form of muscular disease, especially neuromuscular disease pregnancy

Sites / Locations

  • Fachkrankenhaus Kloster Grafschaft

Outcomes

Primary Outcome Measures

Work of breathing, pressure time product

Secondary Outcome Measures

comfort

Full Information

First Posted
August 18, 2006
Last Updated
August 10, 2009
Sponsor
Krankenhaus Kloster Grafschaft
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1. Study Identification

Unique Protocol Identification Number
NCT00366912
Brief Title
Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
No longer recruiting: participants are no longer being recruited or enrolled
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Krankenhaus Kloster Grafschaft

4. Oversight

5. Study Description

Brief Summary
Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation. The study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.
Detailed Description
Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading. A new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements. After a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements. This study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
work of breathing, pressure time product, muscle pressures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
non-invasive ventilation
Primary Outcome Measure Information:
Title
Work of breathing, pressure time product
Secondary Outcome Measure Information:
Title
comfort

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy voluntary individuals PFT within normal limits Exclusion Criteria: Disease of the upper GI-tract Any form of lung disease or disease of the upper airways Any form of muscular disease, especially neuromuscular disease pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic Dellweg, M.D.
Organizational Affiliation
Fachkrankenhaus Kloster Grafschaft
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fachkrankenhaus Kloster Grafschaft
City
Schmallenberg
State/Province
NRW
ZIP/Postal Code
57392
Country
Germany

12. IPD Sharing Statement

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Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode

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