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

July 1, 2010 updated by: Chang Gung Memorial Hospital

Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10507
        • Recruiting
        • Gung Memorial Hospital, Chang Gung University, College of Medicine.
        • Contact:
          • Horng-Chyuan Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute respiratory failure patients in medical ICUs

Exclusion Criteria:

  • Age<20 years old
  • Malignancy
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventilator weaning rate
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU stay
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ANTICIPATED)

March 1, 2011

Study Completion (ANTICIPATED)

March 1, 2011

Study Registration Dates

First Submitted

May 30, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (ESTIMATE)

July 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2010

Last Update Submitted That Met QC Criteria

July 1, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-3276B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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