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Intra-abdominal Pressures During the Spontaneous Breathing Trial (IAP_SBT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797614
First Posted: February 22, 2013
Last Update Posted: February 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
Increased intra-abdominal pressure (IAP) affects pulmonary dynamics. However, little is studied whether pulmonary dynamics affects IAP. We hypothesize that the change of IAP can also reflect the change of pulmonary dynamics. In this study, we choose patients who received spontaneous breathing trial to answer the hypothesis.

Condition
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring the Change of Intra-abdominal Pressures of the Intensive Care Unit Patients During the Spontaneous Breathing Trial

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • To evaluate the patterns of change of IAP during SBT [ Time Frame: 30min, 60min, 120min ]
    30min, 60min, 120min during a 2-hr SBT


Secondary Outcome Measures:
  • To predict success of SBT by the change of IAP [ Time Frame: 0 min, 30 min, 120 min ]
    To predict success of 2-hour IAP the change of IAP between 0 min and 30 min, and tha change of IAP beween 0 min and 120 min

  • To predict weaning success by the change of IAP [ Time Frame: 0 min, 30 min, 120 min ]
    To predict weaning success by the change of IAP between 0 min and 30 min, and tha change of IAP beween 0 min and 120 min


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

During the weaning process, we tapered down the respiratory support from mechanical ventilation and recruited respiratory muscles to work. Previous study showed that transdiaphragmatic pressure was increasing while pressure support was reducing. However, the transdiaphragmatic pressure required invasive procedure to measure and not used frequently in weaning. IAP reflects the pleural pressure. If the PEEP is not changed, change of IAP is largely due to change of transpulmonary pressure.

Study Aim:

  1. To evaluate the patterns of change of IAP during SBT
  2. To predict success of SBT by the change of IAP
  3. To predict weaning outcome by the change of IAP
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with endotracheal intubation and are preparing for weaning assessment
Criteria

Inclusion Criteria:

  • Adult patients with endotracheal intubation in the intensive care unit
  • The clinical condition is considered to prepare for weaning assessment

Exclusion Criteria:

  • tracheostomy
  • severe heart failure, heart disease or arrhythmia
  • upper airway obstruction related respiratory failure
  • poor cooperation due to agitation
  • no foley catheter in place or had been removed
  • baseline IAP above 20 mmHg
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01797614


Contacts
Contact: Nin-Chieh Hsu, MD 886-2-23123456 ext 62557 chesthsu@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Nin-Chieh Hsu Not yet recruiting
Taipei, Taiwan, 100
Contact: Nin-Chieh Hsu, M.D.       chesthsu@gmail.com   
Principal Investigator: Wen-Je Ko, M.D, PhD.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Nin-Chieh Hsu, MD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01797614     History of Changes
Other Study ID Numbers: 201108062RC
First Submitted: February 20, 2013
First Posted: February 22, 2013
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by National Taiwan University Hospital:
intra-abdominal pressure
spontaneous breathing trail
weaning

Additional relevant MeSH terms:
Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes