Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
|ClinicalTrials.gov Identifier: NCT00400881|
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : May 17, 2012
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure||Other: automatic tube compensation||Not Applicable|
The ultimate goal of this proposal is to find the best way to rapidly and safely discontinue mechanical ventilation in patients recovering from respiratory failure.
It is common practice in these patients to perform trials of "spontaneous" breathing while still connected to the ventilator in order to assess their readiness to breathe without assistance. To help with this assessment, new mechanical modes have been incorporated to modern ventilators. A recently developed mode, called Automatic Tube Compensation, is designed for this purpose ("spontaneous" breathing). Whether this method is superior to traditional ones has not been established and the investigators intend to address this question.
The investigators aim to:
- compare Automatic Tube Compensation vs. our traditional mode (Continuous Positive Airway Pressure) during spontaneous breathing trials in their efficacy to identify patients ready be successfully removed from mechanical ventilation
- study which physiologic variables better predict successful discontinuation of mechanical ventilation in these two modes.
The investigators plan to prospectively randomize patients on mechanical ventilation at the point of weaning evaluation, to undergo spontaneous breathing trials with our current ventilatory mode (Continuous Positive Airway Pressure) or the new mode (Automatic Tube Compensation). Based on predefined physiologic and clinical variables, clinicians will decide whether patients are ready to be removed from mechanical ventilation. The proportions of successful discontinuation (no need to reinstitute mechanical ventilation) and the duration of the weaning period in both groups will be compared. During the spontaneous breathing trials, respiratory variables will be measured and compared between patients with successful vs. non successful discontinuation in order to evaluate their predictive value for successful outcome.
Mechanical ventilation is being used increasingly given our growing population with advanced age and multiple co morbidities and the rising volume of aggressive medical procedures. It is well known to be associated with medical complications and high health care costs. Reducing the duration of unnecessary mechanical ventilation while minimizing the risk of premature removal of needed assistance is the final objective of this project. Approaching this goal will decrease the adverse effects of this treatment and the cost of critical care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
No Intervention: Continuous PAP (CPAP)
CPAP (continuous positive airway pressure). 5 cm H2O.
Experimental: Automatic tube compensation (ATC)
ATC is a new mode of ventilation being compared with traditional one (CPAP). ATC is a mode of ventilation of the same device (mechanical ventilator), not a new device. The pressure in this modes varies according the mechanical parameters of the respiratory system that are automatically calculated by this mode. This is the intervention arm.
Other: automatic tube compensation
new mode of ventilation during spontaneous breathing trial. It is a mode of the same device (mechanical ventilator) where the pressure applied by the ventilator varies according to calculations o fthe mechanical properties of the respiratory system automatically performed by the ventilator.
- Duration of Weaning Time [ Time Frame: days ]Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.
- Duration of Mechanical Ventilation [ Time Frame: days ]Duration in days from day of intubation to day of extubation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400881
|United States, Texas|
|University Medical Center Hospital|
|El Paso, Texas, United States, 79905|
|Principal Investigator:||Juan B Figueroa-Casas, MD||Assistant Professor, Texas Tech University HSC|