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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous PAP (CPAP) | No Intervention | CPAP (continuous positive airway pressure). 5 cm H2O. | |
| Automatic tube compensation (ATC) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| automatic tube compensation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation | Duration in days from day of intubation to day of extubation. | days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan B Figueroa-Casas, MD | Assistant Professor, Texas Tech University HSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hospital | El Paso | Texas | 79905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP (Continuous Positive Airway Pressure) | CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group) |
| FG001 | Automatic Tube Compensation (ATC) | ATC mode of ventilation (intervention, not-standard mode) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP (Continuous Positive Airway Pressure) | CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group) |
| BG001 | Automatic Tube Compensation (ATC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | days | days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPAP (Continuous Positive Airway Pressure) | CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group) |
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General ICU population.
Two subjects in each group were randomized and data collected but were not included in analysis per protocol due to needing re-intubation for upper airway obstruction.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan Figueroa-Casas | Texas Tech University | 915 5456626 | 235 | juan.figueroa@ttuhsc.edu |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
ATC mode of ventilation (intervention, not-standard mode)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Duration of Mechanical Ventilation | Duration in days from day of intubation to day of extubation. | 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. | Posted | Mean | Standard Deviation | days | days |
|
|
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| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Automatic Tube Compensation (ATC) | ATC mode of ventilation (intervention, not-standard mode) | 0 | 60 | 0 | 60 |
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