Intra-abdominal Pressures During the Spontaneous Breathin... | NCT01797614

Studies
Intra-abdominal Pressures During the Spontaneous Breathing Trial

NCT01797614

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Feb 22, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Respiratory Failure

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jul 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Feb 20, 2013

First Submission Date that Met QC Criteria

Feb 20, 2013

First Posted Date

Feb 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2013

Last Update Posted Date

Feb 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

To evaluate the patterns of change of IAP during SBT
To predict success of SBT by the change of IAP
To predict weaning outcome by the change of IAP

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the patterns of change of IAP during SBT	30min, 60min, 120min during a 2-hr SBT	30min, 60min, 120min

Secondary Outcomes

Measure	Description	Time Frame
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
To predict weaning success by the change of IAP

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients with endotracheal intubation and are preparing for weaning assessment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nin-Chieh Hsu, MD	Contact	886-2-23123456	62557	chesthsu@gmail.com

Overall Officials

Name	Affiliation	Role
Nin-Chieh Hsu, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nin-Chieh Hsu	Not yet recruiting	Taipei	Taipei	100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided