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

Respiratory Failure Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00366912
• Other study ID #: Aladin 2006
• Status: Terminated
• Phase: N/A
• First received: August 18, 2006
• Last updated: August 10, 2009
• Start date: August 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2009
• Source: Krankenhaus Kloster Grafschaft
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• non-invasive ventilation

Locations

Country	Name	City	State
Germany	Fachkrankenhaus Kloster Grafschaft	Schmallenberg	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Kloster Grafschaft

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work of breathing, pressure time product
Secondary	comfort