Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DUHS parent 3930938 | Other Grant/Funding Number | Covidien |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.
Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RASS plus (BIS) | Experimental | Participants in this arm will receive sedation assessment with the RASS scale augmented with Bispectral Index (BIS) Monitor |
|
| RASS only | No Intervention | Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bispectral Index (BIS) Monitor | Device | BIS monitoring in addition to RASS assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sedative Use | The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation. | Intensive Care Unit (ICU) stay through discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned Self-device Removal Events | The number of unplanned self-device removal events that took place during the study period. | ICU stay through discharge |
| Mean Days on Mechanical Ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| DaiWai M Olson, PhD RN | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
Patients were only excluded from the trial after consent and prior to randomization if they no longer met inclusion criteria, for instance the medical team decided to remove sedatives.
Patients were in the Medical ICU or Neuro ICU at Duke University Hospital or the mixed ICU at Durham Regional. If patients met all inclusion criteria and no exclusion criteria, the attending was asked if patient's legally authorized representative (LAR) could be approached for consent. Enrollment started May of 2008 and closed April of 2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RASS Plus BIS | Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring. |
| FG001 | RASS Only | Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RASS Plus BIS | Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring. |
| BG001 | RASS Only | Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution |
| 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 | Mean Sedative Use | The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation. | All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis. | Posted | Mean | Standard Deviation | ml/hour | Intensive Care Unit (ICU) stay through discharge |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RASS Plus BIS | Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unplanned Self-Device Removal Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DaiWai M Olson, PhD RN | Duke University Health System | (919) 668-3751 | Olson006@mc.duke.edu |
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The mean number of days that the patients were on mechanical ventilation.
| ICU stay- through discharge |
| 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 |
|
|
|
| Secondary | Unplanned Self-device Removal Events | The number of unplanned self-device removal events that took place during the study period. | All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis. | Posted | Number | Event | ICU stay through discharge |
|
|
|
| Secondary | Mean Days on Mechanical Ventilation | The mean number of days that the patients were on mechanical ventilation. | All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis. | Posted | Mean | Standard Deviation | Days | ICU stay- through discharge |
|
|
|
| 0 |
| 155 |
| 0 |
| 155 |
| EG001 | RASS Only | Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution | 0 | 145 | 1 | 145 |
Not provided
Not provided