Spirometry in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | August 24, 2009 | ||||
| Last Updated Date | April 4, 2011 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00965029 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Spirometry in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients | ||||
| Official Title ICMJE | Spirometry in Mechanically Ventilated COPD Patients: Correlation of Lung Function Tests to Successful Weaning From Mechanical Ventilation | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | COPD patients with respiratory failure due to COPD exacerbation, and on mechanical ventilation |
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| Condition ICMJE | COPD | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00965029 | ||||
| Other Study ID Numbers ICMJE | 101/09 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Arie Soroksky, M.D., General ICU, Assaf Harofe Medical Center, Zerifin 70300, Israel | ||||
| Study Sponsor ICMJE | Assaf-Harofeh Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assaf-Harofeh Medical Center | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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