Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

NCT ID: NCT00557999

Last Updated: 2007-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-12-31

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.

Conditions

Mechanical Ventilation; Cardiomyopathy

Keywords

Cardiology; Mechanical ventilation; Intensive care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Application of a weaning mechanical ventilation protocol

Group Type: OTHER

Application of mechanical ventilation weaning protocol

Intervention Type: OTHER

Application protocol for 8 months in experimental group

Control group

Group Type: NO_INTERVENTION

Application of mechanical ventilation weaning protocol

Intervention Type: OTHER

Application protocol for 8 months in experimental group

Interventions

Application of mechanical ventilation weaning protocol

Application protocol for 8 months in experimental group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role: collaborator

Hospital de Base

OTHER

Sponsor Role: lead

Principal Investigators

Lilia N Maia, phD

Role: STUDY_DIRECTOR

Sao Jose do Rio Preto Medical School

Other Identifiers

C71050P

Identifier Type: -

Identifier Source: secondary_id

CAAE-0009.0.140.000-06

Identifier Type: -

Identifier Source: org_study_id