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Spirometry in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965029
First Posted: August 25, 2009
Last Update Posted: April 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose

Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist both in ventilating an obstructed patient and in weaning from mechanical ventilation.

Currently there are no accepted extubation criteria in COPD patients that could predict successful weaning from mechanical ventilation. In this study we will attempt to correlate spirometric data to eventual weaning from mechanical ventilation.


Condition
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spirometry in Mechanically Ventilated COPD Patients: Correlation of Lung Function Tests to Successful Weaning From Mechanical Ventilation

Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Detailed Description:
COPD patients who deteriorate to Respiratory Failure will be recruited. Sedation will be interrupted daily, and each day once the patient is awake and cooperative, spirometry will be performed. FEV1 and FVC will be recorded and later correlated to eventual rate of successful extubation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients with respiratory failure due to COPD exacerbation, and on mechanical ventilation
Criteria

Inclusion Criteria:

  • >18
  • Mechanically ventilated due to COPD exacerbation

Exclusion Criteria:

  • decreased level of consciousness
  • uncooperative patient
  • Bronchial asthma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965029


Contacts
Contact: Arie Soroksky, MD 972-8-9779320 soroksky@gmail.com

Locations
Israel
Arie Soroksky Not yet recruiting
Beer Yaakov, Zerifin, Israel, 70300
Contact: Arie Soroksky, MD    972-8-9779320    soroksky@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Arie Soroksky, MD General ICU, Assaf Harofe MC, Zerifin, Israel
  More Information

Responsible Party: Arie Soroksky, M.D., General ICU, Assaf Harofe Medical Center, Zerifin 70300, Israel
ClinicalTrials.gov Identifier: NCT00965029     History of Changes
Other Study ID Numbers: 101/09
First Submitted: August 24, 2009
First Posted: August 25, 2009
Last Update Posted: April 5, 2011
Last Verified: August 2009

Keywords provided by Assaf-Harofeh Medical Center:
COPD
Spirometry
Weaning

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases