NCT00683072

Brief Summary

Although patient-ventilator asynchrony is a frequent phenomenon, its course following management is unknown. As the aid of a data recording system, we try to observe the consequence of patient-ventilator asynchrony following management. Our target is aimed at the patients with high asynchronization index ( \> 10%) as this group of patients have been shown to have prolonged course in intensive care unit and are also prone to be tracheostomized

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

9 months

First QC Date

May 21, 2008

Last Update Submit

May 22, 2008

Conditions

Respiratory Failure

Keywords

Ventilatorpatient-ventilator asynchrony

Outcome Measures

Primary Outcomes (1)

  • Asynchrony index (AI). (Number of asynchrony events/total respiratory rate)

    20 minutes after alternation of ventilator settings or any therapeutic means

Study Arms (1)

1

Eligibility Criteria

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

Between March 2008 through December 2008, patients admitted to our respiratory intensive care unit for the management of acute respiratory failure were daily screened for the presence of patient-ventilator asynchrony.

You may qualify if:

  • patients admitted to respiratory intensive care unit with acute respiratory failure and presence of patient-ventilator asynchrony(AI of more than 10%)
  • patient can trigger the ventilator

You may not qualify if:

  • High oxygen fraction: \> 60%.
  • High PEEP need: \> 12cmH2O.
  • Hemodynamic unstable: shock
  • Central nervous system problem.
  • Hyperacitve delirium
  • Without informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyPatient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chang wen Chen, MD, MS

    National Cheng-Kung University Hospital

    STUDY DIRECTOR

Central Study Contacts

Kuang Ming Liao, MD

CONTACT

886-6-235-3535abc8870@yahoo.com.tw

Chang Wen Chen, MD, MS

CONTACT

886-6-235-3535cwchen@mail.ncku.edu.tw

Study Design

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

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 23, 2008

Record last verified: 2008-05

Locations

TW(1)