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

NCT01155596 | Unknown Phase 2 DMC

• 1 other identifier: 98-3276B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

Acute respiratory failure patients in medical ICUs.

Outcome Measures

Primary Outcomes (1)

• Ventilator weaning rate

  28 days

Secondary Outcomes (1)

• ICU stay

  28 days

Study Arms (2)

Control group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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

Behavioral: negative pressure ventilator use

Interventions

negative pressure ventilator use BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute respiratory failure patients in medical ICUs

You may not qualify if:

• Age\<20 years old
• Malignancy
• Pregnancy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Taipei, 10507, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Horng-Chyuan Lin

CONTACT

lin53424@ms13.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2010
• First Posted: July 2, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 2, 2010

Record last verified: 2010-06

Locations

TW (1)