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Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00557999
First Posted: November 14, 2007
Last Update Posted: November 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sao Jose do Rio Preto Medical School
Information provided by:
Hospital de Base
  Purpose
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.

Condition Intervention
Mechanical Ventilation Cardiomyopathy Other: Application of mechanical ventilation weaning protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of the Use of Mechanical Ventilation Weaning Protocol in the Coronary Care Unit: A Randomized Study

Further study details as provided by Hospital de Base:

Primary Outcome Measures:
  • Measure: reintubation rates after mechanical ventilation weaning protocol [ Time Frame: 48 hours after extubation ]

Secondary Outcome Measures:
  • Duration of mechanical ventilation weaning [ Time Frame: within the first 7 days after indication of mechanical ventilation weaning ]

Enrollment: 36
Study Start Date: March 2006
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental group
Application of a weaning mechanical ventilation protocol
Other: Application of mechanical ventilation weaning protocol
Application protocol for 8 months in experimental group
No Intervention: Control group Other: Application of mechanical ventilation weaning protocol
Application protocol for 8 months in experimental group

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557999


Sponsors and Collaborators
Hospital de Base
Sao Jose do Rio Preto Medical School
Investigators
Study Director: Lilia N Maia, phD Sao Jose do Rio Preto Medical School
  More Information

ClinicalTrials.gov Identifier: NCT00557999     History of Changes
Other Study ID Numbers: CAAE-0009.0.140.000-06
C71050P
First Submitted: November 13, 2007
First Posted: November 14, 2007
Last Update Posted: November 14, 2007
Last Verified: November 2007

Keywords provided by Hospital de Base:
Cardiology
Mechanical ventilation
Intensive care

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases