NCT01020773

Brief Summary

Spontaneous breathing trial (SBT) has long been thought to be a essential process before extubation. In this study,the investigator hypothesized that SBT could be not essential during weaning from ventilator and investigated whether weaning could be better done without a spontaneous breathing trial in non-COPD（COPD, Chronic Obstructive Pulmonary Disease） critically ill patients. This study has revealed, for the first time, that compared with use of SBT in discontinuing ventilator process, patients underwent successful extubation without SBT. For this subset of patients the findings suggest that SBT may be excluded preceding extubation in a general intensive care population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Status
completed

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

June 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2009

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

November 26, 2009

Completed
Last Updated

November 26, 2009

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

March 21, 2009

Results QC Date

March 21, 2009

Last Update Submit

October 14, 2009

Conditions

Respiratory Failure

Keywords

extubation,Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality

    13 months

Study Arms (2)

SBT group

ACTIVE COMPARATOR

In the SBT group, the patients underwent a 1 hr SBT with inspiratory PS of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.

Behavioral: spontaneous breathing trial

no-SBT group

NO INTERVENTION

In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.

Behavioral: spontaneous breathing trial

Interventions

spontaneous breathing trialBEHAVIORAL
SBT groupno-SBT group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanically Ventilated patient

You may not qualify if:

  • Chronic Obstructive Pulmonary Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Department of Respiratory Medicine
Organization
Beijing Shijitan Hospital
mayingmin@hotmail.com
86-010-63926385

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2009

First Posted

November 26, 2009

Study Start

June 1, 2006

Primary Completion

July 1, 2007

Study Completion

October 1, 2007

Last Updated

November 26, 2009

Results First Posted

November 26, 2009

Record last verified: 2009-10