Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 30, 2010 | ||||
| Last Updated Date | July 1, 2010 | ||||
| Start Date ICMJE | March 2010 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Ventilator weaning rate [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01155596 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
ICU stay [ Time Frame: 28 days ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs) | ||||
| Official Title ICMJE | Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units | ||||
| Brief Summary | This is a Quasi-experimental research design. The subjects are limited in intensive care unit within north medical center hospital. All subjects depend on ventilator and receive weaning plans. Experimental group is weaning with the support of negative pressure ventilator .The investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea scale and arterial blood gas analysis and ventilator weaning index. Compare experimental group and control group data. Data will be Statistical analyzed by: descriptive statistics (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value <0.05 will consider to be statistically significant. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | Respiratory Failure | ||||
| Intervention ICMJE | Behavioral: negative pressure ventilator use
Body ventilators that assist ventilation by applying intermittent subatmospheric pressure around the thorax, abdomen, or airway and periodically expand the chest wall and inflate the lungs. They are relatively simple to operate and do not require tracheostomy. Chest cuirass is used in this study. |
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| Study Arm (s) |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01155596 | ||||
| Other Study ID Numbers ICMJE | 98-3276B | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Horng-Chyuan Lin/ Chief of Division of Pulmonary Infection and Immunity, Department of Thoracic Medicine, Chang Gung Memorial Hospital | ||||
| Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Chang Gung Memorial Hospital | ||||
| Verification Date | June 2010 | ||||
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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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