Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation

June 9, 2015 updated by: Leo Heunks, University Medical Center Nijmegen

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Recruiting
        • Radboud University Nijmegen Medical Center
        • Contact:
        • Sub-Investigator:
          • Jonne Doorduin, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients weaning from mechanical ventilation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Weaning failure
Weaning succes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatiguability of the diaphragm
Time Frame: Multiple measurements within 24 hours after start of weaning trial
Multiple measurements within 24 hours after start of weaning trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Nijmegen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wean1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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