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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
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557999

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

No publications provided

ClinicalTrials.gov Identifier: NCT00557999     History of Changes
Other Study ID Numbers: CAAE-0009.0.140.000-06, C71050P
Study First Received: November 13, 2007
Last Updated: November 13, 2007
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013