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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01155596
First received: May 30, 2010
Last updated: July 1, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Respiratory Failure
 Behavioral: negative pressure ventilator use
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Ventilator weaning rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155596

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

Locations
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

No publications provided

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     History of Changes
Other Study ID Numbers: 98-3276B
Study First Received: May 30, 2010
Last Updated: July 1, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Acute respiratory failure patients in medical ICUs.

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013