NCT01797614

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

1.5 years

First QC Date

February 20, 2013

Last Update Submit

February 20, 2013

Conditions

Respiratory Failure

Keywords

intra-abdominal pressurespontaneous breathing trailweaning

Outcome Measures

Primary Outcomes (1)

  • To evaluate the patterns of change of IAP during SBT

    30min, 60min, 120min during a 2-hr SBT

    30min, 60min, 120min

Secondary Outcomes (2)

  • To predict success of SBT by the change of IAP

    0 min, 30 min, 120 min

  • To predict weaning success by the change of IAP

    0 min, 30 min, 120 min

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with endotracheal intubation and are preparing for weaning assessment

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nin-Chieh Hsu

Taipei, Taipei, 100, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Nin-Chieh Hsu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nin-Chieh Hsu, MD

CONTACT

886-2-23123456chesthsu@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

TW(2)