Mechanical Ventilation Weaning Protocol in the Coronary Care Unit - Full Text View

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

MedlinePlus related topics:

Cardiomyopathy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

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
Control group: No Intervention	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 Medical School

Investigators


Study Director:	Lilia N Maia, phD	Sao Jose do Rio Preto Medical School

More Information

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

Keywords provided by Hospital de Base:

Cardiology

Mechanical ventilation

Intensive care

Study placed in the following topic categories:

Heart Diseases

Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Hospital de Base Sao Jose do Rio Preto Medical School
Information provided by:	Hospital de Base
ClinicalTrials.gov Identifier:	NCT00557999