Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
Pilot Study on the Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
1 other identifier
observational
20
1 country
1
Brief Summary
The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJune 10, 2015
June 1, 2015
5.7 years
June 1, 2010
June 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fatiguability of the diaphragm
Multiple measurements within 24 hours after start of weaning trial
Study Arms (2)
Weaning failure
Weaning succes
Eligibility Criteria
ICU patients weaning from mechanical ventilation
You may qualify if:
- age \> 18 year
- mechanical ventilation for at least 3 days
- the treating physician judges the patient to be ready to be weaned from the ventilator
- informed consent
You may not qualify if:
- pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
- upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
- recent (\< 1 month) nasal bleeding
- phrenic nerve lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525GA, Netherlands
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 2, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
June 10, 2015
Record last verified: 2015-06