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Slow recruitment of subjects
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The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-assisted weaning | Experimental | Group assigned to the computer-assisted weaning program |
|
| Standard of care weaning | Active Comparator | Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-assisted weaning program | Device | Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Weaning | Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted. | Continuous (median weaning duration was 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ICU Stay | Duration of ICU stay after weaning initiation | from start of weaning to discharge from ICU, on average 1-2 weeks |
| Duration of Mechanical Ventilation | Duration of mechanical ventilation from weaning initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine C Reardon, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| Label | URL |
|---|---|
| BUMC Pulmonary Center Home Page | View source |
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Recruitment start 1/2008 recruitment end: 5/2010 Recruited from Medical Intensive Care Unites Boston medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Computer-assisted Wean | Group assigned to the computer-assisted weaning program Intervention Group |
| FG001 | Standard of Care | Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Computer-assisted Wean | Group assigned to the computer-assisted weaning program Intervention Group |
| BG001 | Standard of Care | Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted. | ITT | Posted | Median | Inter-Quartile Range | Days | Continuous (median weaning duration was 2 days) |
|
Duration of hospitalization after initiation of mechanical ventilation. Median 20 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 | Computer-assisted Wean | Group assigned to the computer-assisted weaning program Intervention Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Need for Tracheostomy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | unable to be weaned from ventilator, required tracheostomy for long term ventilation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High pressure support level reached | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | In one participant with a baseline PaCO2 level > 60mmHg, the computer-driven weaning system (SmartCare) increased delivered pressure support to 40cm H2O in an attempt to decrease end tidal CO2 to less then 60. No adverse clinical outcomes resulted. |
This trial was terminated early due to slow recruitment. It did not reach the target N of 220.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allan Walkey, MD, MSc | Boston University School of Medicine | 617-638-4860 | alwalkey@bu.edu |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Standard of Care weaning | Behavioral | Evidence-based standard of care weaning process. |
|
| from start of weaning to liberation from ventilator, on average 1-2 days |
| Duration of Hospitalization | from start of weaning to discharge from hospital, on average 1-2 weeks |
| Inpatient Mortality | proportion of patients in each arm who died in the hospital | 28 days |
| Sedation Requirements | measure was not recorded | during weaning, on average 1-2 days |
| Number of Spontaneous Breathing Trials Prior to Extubation | from start of weaning to liberation from ventilator, on average 1-2 days |
| Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) | This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications. | Duration of weaning (median 2 days) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| APACHE II Score | Acute Physiology and Chronic Health Evaluation Score Range 0-72 Higher score indicates more severe illness | Mean | Standard Deviation | score |
|
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| Secondary | Duration of ICU Stay | Duration of ICU stay after weaning initiation | Posted | Median | Inter-Quartile Range | days | from start of weaning to discharge from ICU, on average 1-2 weeks |
|
|
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| Secondary | Duration of Mechanical Ventilation | Duration of mechanical ventilation from weaning initiation | Posted | Median | Inter-Quartile Range | days | from start of weaning to liberation from ventilator, on average 1-2 days |
|
|
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| Secondary | Duration of Hospitalization | Posted | Median | Inter-Quartile Range | days | from start of weaning to discharge from hospital, on average 1-2 weeks |
|
|
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| Secondary | Inpatient Mortality | proportion of patients in each arm who died in the hospital | ITT | Posted | Number | Participants | 28 days |
|
|
|
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| Secondary | Sedation Requirements | measure was not recorded | Data were not recorded | Posted | during weaning, on average 1-2 days |
|
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| Secondary | Number of Spontaneous Breathing Trials Prior to Extubation | Posted | Median | Inter-Quartile Range | SBTs | from start of weaning to liberation from ventilator, on average 1-2 days |
|
|
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| Secondary | Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) | This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications. | Number of participants with adverse event during weaning | Posted | Number | Participants | Duration of weaning (median 2 days) |
|
|
|
|
| 1 |
| 15 |
| 7 |
| 15 |
| 1 |
| 15 |
| EG001 | Standard of Care | Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. Comparator group | 6 | 18 | 8 | 18 | 0 | 18 |
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| Ventilator associated pneumonia | Infections and infestations | Systematic Assessment |
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| Death during weaning process | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Re-intubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | required placement back on mechanical ventilator using endotracheal tube after intial extubations |
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| Self-extubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | patient removed endotracheal tube prior to physician order. |
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| Non-invasive ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | received non-invasive mechanical ventilator through a mask after extubation |
|
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