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TerminatedNCT00366912Updated Aug 11, 2009

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

An interventional study of non-invasive ventilation in Respiratory Failure, sponsored by Krankenhaus Kloster Grafschaft. Terminated at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-11.

Sponsored by Krankenhaus Kloster Grafschaft · Not applicable, Interventional, and Treatment

Why this study was terminated
No longer recruiting: participants are no longer being recruited or enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Failure

Keywords

  • work of breathing
  • pressure time product
  • muscle pressures
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 10 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Krankenhaus Kloster Grafschaft is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy voluntary individuals
  • PFT within normal limits

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants

Interventions

  • Devicenon-invasive ventilation
06

What researchers measure

Primary outcomes

  1. Work of breathing, pressure time product

Secondary outcomes

  1. comfort

07

Study locations

1 site
  • Fachkrankenhaus Kloster Grafschaft
    Schmallenberg, NRW 57392, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00366912
Lead sponsor
Krankenhaus Kloster Grafschaft
First posted
Aug 21, 2006
Start date
Aug 2006
Completion
Apr 2007
Last update
Aug 11, 2009

Study contacts

Dominic Dellweg, M.D.
principal investigator · Fachkrankenhaus Kloster Grafschaft
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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