Respiratory Insufficiency
Conditions
Keywords
Respiratory Insufficiency, Ventilators, Mechanical, Ventilator Weaning, Therapy, Computer-Assisted
Brief summary
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.
Interventions
DEVICEComputer-assisted weaning program
Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
BEHAVIORALStandard of Care weaning
Evidence-based standard of care weaning process.
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * Initiated on mechanical ventilation via endotracheal tube * Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion) * Requiring mechanical ventilation for more than 48 hours * Meets prespecified weaning criteria
Exclusion criteria
* Do Not Resuscitate/Do Not Intubate order * Pregnancy * Mechanical ventilation initiated at another hospital * Cardiac arrest for more than 5 minutes with poor neurologic prognosis * Tracheostomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Weaning | Continuous (median weaning duration was 2 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | from start of weaning to liberation from ventilator, on average 1-2 days | Duration of mechanical ventilation from weaning initiation |
| Duration of Hospitalization | from start of weaning to discharge from hospital, on average 1-2 weeks | — |
| Inpatient Mortality | 28 days | proportion of patients in each arm who died in the hospital |
| Duration of ICU Stay | from start of weaning to discharge from ICU, on average 1-2 weeks | Duration of ICU stay after weaning initiation |
| 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) | Duration of weaning (median 2 days) | This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications. |
| Sedation Requirements | during weaning, on average 1-2 days | measure was not recorded |
Countries
United States
Participant flow
Recruitment details
Recruitment start 1/2008 recruitment end: 5/2010 Recruited from Medical Intensive Care Unites Boston medical Center
Participants by arm
| Arm | Count |
|---|---|
| Computer-assisted Wean Group assigned to the computer-assisted weaning program Intervention Group | 15 |
| Standard of Care Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Comparator group | 18 |
| Total | 33 |
Baseline characteristics
| Characteristic | Computer-assisted Wean | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 21 | 60.5 years STANDARD_DEVIATION 15.5 | 55.7 years STANDARD_DEVIATION 18.9 |
| APACHE II Score | 23.3 score STANDARD_DEVIATION 7.7 | 26.5 score STANDARD_DEVIATION 7.1 | 25 score STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 6 / 18 |
| other Total, other adverse events | 1 / 15 | 0 / 18 |
| serious Total, serious adverse events | 7 / 15 | 8 / 18 |
Outcome results
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.
Time frame: Continuous (median weaning duration was 2 days)
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Computer-assisted Wean | Duration of Weaning | 1.92 Days |
| Standard of Care | Duration of Weaning | 2.15 Days |
p-value: 0.6Wilcoxon (Mann-Whitney)
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.
Time frame: Duration of weaning (median 2 days)
Population: Number of participants with adverse event during weaning
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Computer-assisted Wean | Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) | 7 Participants |
| Standard of Care | Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) | 8 Participants |
p-value: 0.9Chi-squared
Secondary
Duration of Hospitalization
Time frame: from start of weaning to discharge from hospital, on average 1-2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Computer-assisted Wean | Duration of Hospitalization | 19.1 days |
| Standard of Care | Duration of Hospitalization | 19.7 days |
Secondary
Duration of ICU Stay
Duration of ICU stay after weaning initiation
Time frame: from start of weaning to discharge from ICU, on average 1-2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Computer-assisted Wean | Duration of ICU Stay | 10.2 days |
| Standard of Care | Duration of ICU Stay | 15 days |
Secondary
Duration of Mechanical Ventilation
Duration of mechanical ventilation from weaning initiation
Time frame: from start of weaning to liberation from ventilator, on average 1-2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Computer-assisted Wean | Duration of Mechanical Ventilation | 1.91 days |
| Standard of Care | Duration of Mechanical Ventilation | 2.15 days |
Secondary
Inpatient Mortality
proportion of patients in each arm who died in the hospital
Time frame: 28 days
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Computer-assisted Wean | Inpatient Mortality | 1 Participants |
| Standard of Care | Inpatient Mortality | 6 Participants |
p-value: 0.06Chi-squared
Secondary
Number of Spontaneous Breathing Trials Prior to Extubation
Time frame: from start of weaning to liberation from ventilator, on average 1-2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Computer-assisted Wean | Number of Spontaneous Breathing Trials Prior to Extubation | 0 SBTs |
| Standard of Care | Number of Spontaneous Breathing Trials Prior to Extubation | 1 SBTs |
Secondary
Sedation Requirements
measure was not recorded
Time frame: during weaning, on average 1-2 days
Population: Data were not recorded