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Status unknownNCT00415896Updated Dec 25, 2006

Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

An interventional study of positive pressure ventilation in Chronic Respiratory Failure, sponsored by Krankenhaus Kloster Grafschaft. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-12-25.

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

The sponsor has not verified this record recently (last verified Dec 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Chronic Respiratory Failure

Keywords

  • weaning
  • work of breathing
  • spontaneous breathing trial
  • rapid shallow breathing
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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • hypercapnic respiratory failure

Exclusion criteria

Exclusion Criteria:

  • upper Gi pathology
  • renal failure (creatinin > 2 mg/dl)
  • Sepsis or infection
  • age \< 18 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
10 participants

Interventions

  • Devicepositive pressure ventilation
06

What researchers measure

Primary outcomes

  1. Endurance time

Secondary outcomes

  1. PCO2, respiratory parameters

07

Study locations

1 of 1 sites recruiting
  • Kloster Grafschaft
    Schmallenberg, Annostr. 1 57392, Germany
    • Dominic Dellweg, M.D. · Contact · d.dellweg@fkkg.de · +49 2972 791
    • Dieter Koehler, M.D. Prof. · Contact · d.koehler@fkkg.de · +49 2972 791
    • Stefan Boeckling · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 25, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00415896
Lead sponsor
Krankenhaus Kloster Grafschaft
First posted
Dec 25, 2006
Start date
Dec 2006
Completion
Jun 2007
Last update
Dec 25, 2006

Study contacts

Dominic Dellweg, M.D.
Contact
d.dellweg@fkkg.de
+49 2972 791 ext. 1257
Dieter Koehler, M.D. Prof.
Contact
d.koehler@fkkg.de
+40 2972 791 ext. 2500
Dominic Dellweg, M.D.
principal investigator · FKKG
Dieter Koehler, M.D., Prof.
study chair · FKKG
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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