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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
Hospital de Base
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation focused on measuring Cardiology, Mechanical ventilation, Intensive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 13, 2007
    Last Updated
    November 13, 2007
    Sponsor
    Hospital de Base
    Collaborators
    Sao Jose do Rio Preto Medical School
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    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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