Respiratory Failure
Conditions
Keywords
mechanical ventilation, weaning, respiratory failure, spontaneous breathing trial
Brief summary
To compare a new mode of mechanical ventilation, Automatic Tube Compensation (ATC) with a traditional one, Continuous Positive Airway Pressure(CPAP), on its effectiveness for detecting patients no longer needing mechanical ventilation.
Detailed description
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: 1. 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 2. 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.
Interventions
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.
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients 18 years of age or older * on mechanical ventilation at Thomason Hospital Intensive Care Unit for more than 24 hours * about to undergo SBT by the current institutional protocol for weaning assessment ordered by their treating physician * availability of informed consent from patient or next of kin
Exclusion criteria
* patients for whom a decision has been made not to reinstitute ventilatory assistance under any circumstance * pregnancy * patients not considered for discontinuation of mechanical ventilation on the day of SBT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Weaning Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | days | Duration in days from day of intubation to day of extubation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPAP (Continuous Positive Airway Pressure) CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group) | 62 |
| Automatic Tube Compensation (ATC) ATC mode of ventilation (intervention, not-standard mode) | 60 |
| Total | 122 |
Baseline characteristics
| Characteristic | Automatic Tube Compensation (ATC) | CPAP (Continuous Positive Airway Pressure) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 55 Participants | 105 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 20 | 51 years STANDARD_DEVIATION 19 | 51 years STANDARD_DEVIATION 20 |
| Region of Enrollment United States | 60 participants | 62 participants | 122 participants |
| Sex: Female, Male Female | 18 Participants | 25 Participants | 43 Participants |
| Sex: Female, Male Male | 42 Participants | 37 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 60 |
| serious Total, serious adverse events | 0 / 62 | 0 / 60 |
Outcome results
Primary
Duration of Weaning Time
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.
Time frame: days
Population: All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPAP | Duration of Weaning Time | 0.18 days | Standard Deviation 0.5 |
| ATC (ATComp) | Duration of Weaning Time | 0.05 days | Standard Deviation 0.3 |
Secondary
Duration of Mechanical Ventilation
Duration in days from day of intubation to day of extubation.
Time frame: days
Population: Analysis per protocol. All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPAP | Duration of Mechanical Ventilation | 4.9 days | Standard Deviation 3.4 |
| ATC (ATComp) | Duration of Mechanical Ventilation | 5.1 days | Standard Deviation 4.2 |