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Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)

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ClinicalTrials.gov Identifier: NCT01155596
Recruitment Status : Unknown
Verified June 2010 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : July 2, 2010
Last Update Posted : July 2, 2010
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Behavioral: negative pressure ventilator use Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units
Study Start Date : March 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Base on positive pressure ventilation with intubation and mechanical ventilator, weaning processes will undergo by Pulmonologists.
Experimental: Experimental group
Experimental group is weaning with the support of negative pressure ventilator.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Ventilator weaning rate [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute respiratory failure patients in medical ICUs

Exclusion Criteria:

  • Age<20 years old
  • Malignancy
  • Pregnancy
Contacts and Locations
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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): NCT01155596


Contacts
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Contact: Horng-Chyuan Lin lin53424@ms13.hinet.net

Locations
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Taiwan
Gung Memorial Hospital, Chang Gung University, College of Medicine. Recruiting
Taipei, Taiwan, 10507
Contact: Horng-Chyuan Lin         
Sponsors and Collaborators
Chang Gung Memorial Hospital
More Information
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Responsible Party: Horng-Chyuan Lin/ Chief of Division of Pulmonary Infection and Immunity, Department of Thoracic Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01155596    
Other Study ID Numbers: 98-3276B
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: July 2, 2010
Last Verified: June 2010
Keywords provided by Chang Gung Memorial Hospital:
Acute respiratory failure patients in medical ICUs.
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases