Mechanical Ventilation Weaning Protocol in the Coronary Care Unit
Primary Purpose
Mechanical Ventilation, Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Application of mechanical ventilation weaning protocol
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Ventilation focused on measuring Cardiology, Mechanical ventilation, Intensive care
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Application of a weaning mechanical ventilation protocol
Outcomes
Primary Outcome Measures
Measure: reintubation rates after mechanical ventilation weaning protocol
Secondary Outcome Measures
Duration of mechanical ventilation weaning
Full Information
NCT ID
NCT00557999
First Posted
November 13, 2007
Last Updated
November 13, 2007
Sponsor
Hospital de Base
Collaborators
Sao Jose do Rio Preto Medical School
1. Study Identification
Unique Protocol Identification Number
NCT00557999
Brief Title
Mechanical Ventilation Weaning Protocol in the Coronary Care Unit
Official Title
Evaluation of the Effects of the Use of Mechanical Ventilation Weaning Protocol in the Coronary Care Unit: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Base
Collaborators
Sao Jose do Rio Preto Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Cardiomyopathy
Keywords
Cardiology, Mechanical ventilation, Intensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Other
Arm Description
Application of a weaning mechanical ventilation protocol
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Application of mechanical ventilation weaning protocol
Intervention Description
Application protocol for 8 months in experimental group
Primary Outcome Measure Information:
Title
Measure: reintubation rates after mechanical ventilation weaning protocol
Time Frame
48 hours after extubation
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation weaning
Time Frame
within the first 7 days after indication of mechanical ventilation weaning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilia N Maia, phD
Organizational Affiliation
Sao Jose do Rio Preto Medical School
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Mechanical Ventilation Weaning Protocol in the Coronary Care Unit
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