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NCT01135121 Clinical Trial

Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation

Weaning Clinical Trial

Official title:
Pilot Study on the Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01135121
Other study ID # Wean1
Secondary ID
Status Recruiting
Phase N/A
First received June 1, 2010
Last updated June 9, 2015
Start date May 2010
Est. completion date January 2016

Study information
Verified date June 2015
Source University Medical Center Nijmegen
Contact Leo Heunks, MD, PhD
Phone +31 24 3617273
Email L.Heunks@ic.umcn.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Radboud University Nijmegen Medical Center Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fatiguability of the diaphragm Multiple measurements within 24 hours after start of weaning trial No
See also
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