NCT00366912

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

First QC Date

August 18, 2006

Last Update Submit

August 10, 2009

Conditions

Respiratory Failure

Keywords

work of breathingpressure time productmuscle pressures

Outcome Measures

Primary Outcomes (1)

  • Work of breathing, pressure time product

Secondary Outcomes (1)

  • comfort

Interventions

non-invasive ventilationDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy voluntary individuals
  • PFT within normal limits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fachkrankenhaus Kloster Grafschaft

Schmallenberg, North Rhine-Westphalia, 57392, Germany

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Dominic Dellweg, M.D.

    Fachkrankenhaus Kloster Grafschaft

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 21, 2006

Study Start

August 1, 2006

Study Completion

April 1, 2007

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

DE(1)