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

Primary Purpose

Respiratory Failure

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
negative pressure ventilator use
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Respiratory Failure focused on measuring Acute respiratory failure patients in medical ICUs.

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute respiratory failure patients in medical ICUs

Exclusion Criteria:

  • Age<20 years old
  • Malignancy
  • Pregnancy

Sites / Locations

  • Gung Memorial Hospital, Chang Gung University, College of Medicine.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Base on positive pressure ventilation with intubation and mechanical ventilator, weaning processes will undergo by Pulmonologists.

Experimental group is weaning with the support of negative pressure ventilator.

Outcomes

Primary Outcome Measures

Ventilator weaning rate

Secondary Outcome Measures

ICU stay

Full Information

First Posted
May 30, 2010
Last Updated
July 1, 2010
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01155596
Brief Title
Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)
Official Title
Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Acute respiratory failure patients in medical ICUs.

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Base on positive pressure ventilation with intubation and mechanical ventilator, weaning processes will undergo by Pulmonologists.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group is weaning with the support of negative pressure ventilator.
Intervention Type
Behavioral
Intervention Name(s)
negative pressure ventilator use
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator weaning rate
Time Frame
28 days
Secondary Outcome Measure Information:
Title
ICU stay
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute respiratory failure patients in medical ICUs Exclusion Criteria: Age<20 years old Malignancy Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horng-Chyuan Lin
Email
lin53424@ms13.hinet.net
Facility Information:
Facility Name
Gung Memorial Hospital, Chang Gung University, College of Medicine.
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horng-Chyuan Lin

12. IPD Sharing Statement

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

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