Intra-abdominal Pressures During the Spontaneous Breathing Trial

• Conditions: Respiratory Failure

• Registration Number: NCT01797614
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

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

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Last Update Submitted: 2013-02-20
• Study First Posted: 2013-02-22
• Last Update Posted: 2013-02-22
• Primary Completion: 2013-07
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the patterns of change of IAP during SBT	30min, 60min, 120min	30min, 60min, 120min during a 2-hr SBT

Secondary Outcome Measures

Name	Time	Method
To predict success of SBT by the change of IAP	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	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

Trial Locations

Locations (2)

Nin-Chieh Hsu; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan