NCT00557999

Brief Summary

The following objectives were used for comparison: 1) primary objective: reintubation rate during hospitalization; 2) secondary objectives: length of hospitalization at the Coronary Care Unit; time from intubation to start of weaning; time from start of weaning to extubation; time from SBT and extubation; presence of respiratory infection in patients requiring reintubation; mortality of patients requiring reintubation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

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

March 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

November 13, 2007

Last Update Submit

November 13, 2007

Conditions

Mechanical VentilationCardiomyopathy

Keywords

CardiologyMechanical ventilationIntensive care

Outcome Measures

Primary Outcomes (1)

  • Measure: reintubation rates after mechanical ventilation weaning protocol

    48 hours after extubation

Secondary Outcomes (1)

  • Duration of mechanical ventilation weaning

    within the first 7 days after indication of mechanical ventilation weaning

Study Arms (2)

Experimental group

OTHER

Application of a weaning mechanical ventilation protocol

Other: Application of mechanical ventilation weaning protocol

Control group

NO INTERVENTION
Other: Application of mechanical ventilation weaning protocol

Interventions

Application of mechanical ventilation weaning protocolOTHER

Application protocol for 8 months in experimental group

Control groupExperimental group

Eligibility Criteria

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

You may qualify if:

  • patients hospitalized at the CCU with MV for over 24 hours;
  • age over 18 years;
  • both genders;
  • patients capable of spontaneous ventilation;
  • patients with indication for MV weaning.

You may not qualify if:

  • conditions and/or circumstances that might result in difficulty to understand the informed consent (psychiatric disorder, alcohol or drug addiction, mental disability);
  • patient denies to sign the informed consent;
  • end-stage diseases and
  • dependence on mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lilia N Maia, phD

    Sao Jose do Rio Preto Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 14, 2007

Study Start

March 1, 2006

Study Completion

December 1, 2006

Last Updated

November 14, 2007

Record last verified: 2007-11