Mechanical Ventilation Weaning Clinical Trial
Official title:
New Integrated Weaning Indexes From Mechanical Ventilation: A Prospective Clinical Trial
The purpose of this study is to determine whether introducing the new weaning indexes can predict better than traditional ones?
The study was divided into two parts: First, the threshold values of the indexes that
discriminated best between successful weaning and weaning failure were determined in
training set (n = 208). Second, the accuracy of each index was scrutinized prospectively in
an additional group of patients (prospective-validation data set, n = 967). One thousand one
hundred and seventy-five patients who were on mechanical ventilation for more than 24 hours
were evaluated.Informed consent was obtained from each patient, whenever possible, or from
the patient's next of kin. The samples were selected using a simple random sampling method
in which the entry number of eligible patients was considered to be the sampling ID number.
Using Random Allocation Software (RAS), random numbers were generated to select the study
participant.
The ventilators used were Evita XL and Evita 4 edition (Draeger, Lubeck, Germany).
According to a protocol that have introduced in two studies, the protocol established. All
of the mechanically ventilated patients undergoing assessment for extubation undergo a daily
SBT if predetermined eligibility criteria for weaning are met . According to this protocol,
sedation would be discontinued before evaluation of weaning. Patients who meet these
criteria are initially placed on SBT (continuous positive airway pressure of 5 mmHg,
FiO2≤0.4) for 3 minutes to obtain weaning parameters. If the Oxygen saturation is ≥ 92% on
pulse oximetry with FiO2≤0.4 and RSBI <104 breaths/minute/L, patients are continued on the
SBT for 30 to 120 minutes. All clinical and ventilator parameters are monitored closely for
signs of respiratory distress (respiratory rate > 30 breaths/minute, SaO2< 90%, heart rate >
140 breaths/minute, or a sustained increase or decrease of heart rate of >20%, blood
pressure>200 mm Hg or <80 mm Hg, and agitation, diaphoresis, or anxiety). At the end of the
SBT, the RSBI is measured again, ABG is obtained, and the predetermined values are
calculated and measured. The decision to return to mechanical ventilation made by the two
subspecialists in pulmonary and lung diseases, who were chief supervisor of both ICU in two
cities (who were completely blind to the study and the results of the indexes evaluated),
based on airway competence (cough, sputum production, neurologic status, level of
consciousness, and maximal inspiratory pressure). Patients who remain extubated at 48 hours
are classified as having had a successful extubation. Baseline demographics, initial
diagnosis, and pre-extubation clinical, ventilator, laboratory, and radiographic data are
collected for each patient.
To assess the prognostic value of new indices, receiver operator characteristic (ROC) curves
was drawn for each formula in addition for other conventional criteria used in this area.
For each ROC curve analysis, sensitivity, Specificity, Positive Predictive Value, Negative
Predictive Value, diagnostic accuracy, likelihood ratio of a positive test (LR+) and the
likelihood ratio of a negative test (LR-), probability for weaning success when test is
positive and probability for weaning success when test is negative of the indexes were used
to predict the weaning outcome in the prospective-validation data set.
Hanley and McNeil method was used to calculate the area under curve (AUC) for each formula
and then the methods developed by the same authors were used to compare these AUCs. Bayes'
theorem was used to compute the weaning outcome the probability for weaning success when
test is positive and negative (post-test probability) in the prospective-validation data set
to assess the perform
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Observational Model: Cohort, Time Perspective: Prospective
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