NCT00415896

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 25, 2006

Status Verified

December 1, 2006

First QC Date

December 22, 2006

Last Update Submit

December 22, 2006

Conditions

Chronic Respiratory Failure

Keywords

weaningwork of breathingspontaneous breathing trialrapid shallow breathing

Outcome Measures

Primary Outcomes (1)

  • Endurance time

Secondary Outcomes (1)

  • PCO2, respiratory parameters

Interventions

positive pressure ventilationDEVICE

Eligibility Criteria

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

You may qualify if:

  • hypercapnic respiratory failure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kloster Grafschaft

Schmallenberg, Annostr. 1, 57392, Germany

RECRUITING

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Dominic Dellweg, M.D.

    FKKG

    PRINCIPAL INVESTIGATOR

  • Dieter Koehler, M.D., Prof.

    FKKG

    STUDY CHAIR

Central Study Contacts

Dominic Dellweg, M.D.

CONTACT

+49 2972 791d.dellweg@fkkg.de

Dieter Koehler, M.D. Prof.

CONTACT

+40 2972 791d.koehler@fkkg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

December 1, 2006

Study Completion

June 1, 2007

Last Updated

December 25, 2006

Record last verified: 2006-12

Locations

DE(1)