Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Effects of the Use of Mechanical Ventilation Weaning Protocol in the Coronary Care Unit: A Randomized Study

Conditions
-----------------
Mechanical Ventilation, Cardiomyopathy

Intervention / Treatment
-----------------
* Other: Application of mechanical ventilation weaning protocol


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental group<br>Application of a weaning mechanical ventilation protocol | Other: Application of mechanical ventilation weaning protocol<br>* Application protocol for 8 months in experimental group<br>|
| No Intervention: Control group<br> | Other: Application of mechanical ventilation weaning protocol<br>* Application protocol for 8 months in experimental group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: reintubation rates after mechanical ventilation weaning protocol |  | 48 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation weaning |  | within the first 7 days after indication of mechanical ventilation weaning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiology, Mechanical ventilation, Intensive care