Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

This study has been completed.
Sponsor:
Collaborator:
Sao Jose do Rio Preto University
Information provided by:
Hospital de Base
ClinicalTrials.gov Identifier:
NCT00557999
First received: November 13, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 13, 2007
November 13, 2007
March 2006
Not Provided
Measure: reintubation rates after mechanical ventilation weaning protocol [ Time Frame: 48 hours after extubation ]
Same as current
No Changes Posted
Duration of mechanical ventilation weaning [ Time Frame: within the first 7 days after indication of mechanical ventilation weaning ]
Same as current
Not Provided
Not Provided
 
Mechanical Ventilation Weaning Protocol in the Coronary Care Unit
Evaluation of the Effects of the Use of Mechanical Ventilation Weaning Protocol in the Coronary Care Unit: A Randomized Study

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.

Once the cause leading to the need of MV was resolved, patients from both groups underwent a daily clinical evaluation in the mornings, to determine whether they were ready for mechanical ventilation weaning, according to the following clinical SBT criteria: 1) Cause of MV: resolution of the cause and abnormalities leading to MV; 2) neurological stability: patient awake, without or with minimal infusion of sedatives/narcotics, with effective cough and Glasgow scale ≥ 9; 3) cardiovascular stability: mean blood pressure (MBP) ≥ 60 mm Hg, without vasopressors or with low vasopressor doses, heart rate (HR) ≤ 140 / min, hemoglobin (Hb) ≥ 8,0 - 10,0 g/L, partial arterial oxygen pressure (PaO2) ≥ 60 mm Hg with fraction of inhaled oxygen (FiO2) ≤ 0.4, oxygenation index (PaO2 / FiO2) ≥ 150 - 300 without significant respiratory acidosis; 4) metabolic stability: temperature < 37.8° C (armpit) and lack of hydroelectrolytic disorders.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mechanical Ventilation
  • Cardiomyopathy
Other: Application of mechanical ventilation weaning protocol
Application protocol for 8 months in experimental group
  • Experimental group
    Application of a weaning mechanical ventilation protocol
    Intervention: Other: Application of mechanical ventilation weaning protocol
  • No Intervention: Control group
    Intervention: Other: Application of mechanical ventilation weaning protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2006
Not Provided

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00557999
CAAE-0009.0.140.000-06, C71050P
No
Not Provided
Hospital de Base
Sao Jose do Rio Preto University
Study Director: Lilia N Maia, phD Sao Jose do Rio Preto University
Hospital de Base
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP