Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557999
• Other study ID #: CAAE-0009.0.140.000-06
• Secondary ID: C71050P
• Status: Completed
• Phase: N/A
• First received: November 13, 2007
• Last updated: November 13, 2007
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: November 2007
• Source: Hospital de Base
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Mechanical Ventilation

Intervention

Other:
• Application of mechanical ventilation weaning protocol
Application protocol for 8 months in experimental group

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Base	Sao Jose do Rio Preto University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: reintubation rates after mechanical ventilation weaning protocol		48 hours after extubation
Secondary	Duration of mechanical ventilation weaning		within the first 7 days after indication of mechanical ventilation weaning