Intra-abdominal Pressures During the Spontaneous Breathing Trial

Respiratory Failure Clinical Trial

— IAP_SBT  

Official title:

Measuring the Change of Intra-abdominal Pressures of the Intensive Care Unit Patients During the Spontaneous Breathing Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01797614
• Other study ID #: 201108062RC
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2013
• Last updated: February 20, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: National Taiwan University Hospital
• Contact: Nin-Chieh Hsu, MD
• Phone: 886-2-23123456
• Email: chesthsu[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Nin-Chieh Hsu	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the patterns of change of IAP during SBT	30min, 60min, 120min during a 2-hr SBT	30min, 60min, 120min	No
Secondary	To predict success of SBT by the change of IAP	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	0 min, 30 min, 120 min	No
Secondary	To predict weaning success by the change of IAP	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	0 min, 30 min, 120 min	No