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Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00557999
Enrollment
36
Registered
2007-11-14
Start date
2006-03-31
Completion date
2006-12-31
Last updated
2007-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Mechanical Ventilation

Keywords

Cardiology, Mechanical ventilation, Intensive care

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.

Interventions

OTHERApplication of mechanical ventilation weaning protocol

Application protocol for 8 months in experimental group

Sponsors

Sao Jose do Rio Preto Medical School
CollaboratorOTHER
Hospital de Base
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Measure: reintubation rates after mechanical ventilation weaning protocol48 hours after extubation

Secondary

MeasureTime frame
Duration of mechanical ventilation weaningwithin the first 7 days after indication of mechanical ventilation weaning

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026