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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL150404 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| Cooper University Health Care | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated emergency department patients at three academic medical centers: Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City, IA). The overall goal is to assess the feasibility of implementing targeted sedation (in terms of sedation depth) for mechanically ventilated ED patients in order to reduce the incidence of unnecessary deep sedation and improve clinical outcomes.
The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated ED patients at three academic medical centers. Patients in the before phase of the study will receive usual care after the initiation of mechanical ventilation. After 172 patients have been enrolled in the before phase, the investigators will begin educational initiatives to implement ED-based sedation protocols and order sets. The research team will educate providers on the importance of sedation protocols on patient outcome so that the existing protocols begin to be used effectively in the ED. This educational initiative will allow targeted sedation to be effectively used in the ED as well, allowing the intervention to be tested under real-world conditions. Participants in the after phase will also receive standard post-intubation care at the discretion of the treating team, though it will be after the educational initiative aimed at improving post-intubation sedation.
In order to more effectively use sedation in the ED, the investigators will collect voluntary and anonymous surveys from ED nurses and physicians to assess the potential facilitators and barriers to adherence to guideline-recommended sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before group | Other | Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation |
|
| After group | Other | Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Recruitment | Count of eligible participants included in study | Through study completion, an average of 1 year |
| Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range | Deep sedation defined as RASS of -3 to -5 Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable | Up to 12 hours (during mechanical ventilation in the emergency department) |
| Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED | Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers. | Up to 12 hours (during mechanical ventilation in the emergency department) |
| Number of Participants With Adverse Events | Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events | Up to 12 hours (during mechanical ventilation in the emergency department) |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free Days | To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days. | Up to 28 days |
| ICU-free Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Fuller, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Washington University School of Medicine/Barnes-Jewish Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35866657 | Derived | Fuller BM, Pappal RD, Mohr NM, Roberts BW, Faine B, Yeary J, Sewatsky T, Johnson NJ, Driver BE, Ablordeppey E, Drewry AM, Wessman BT, Yan Y, Kollef MH, Carpenter CR, Avidan MS. Awareness With Paralysis Among Critically Ill Emergency Department Patients: A Prospective Cohort Study. Crit Care Med. 2022 Oct 1;50(10):1449-1460. doi: 10.1097/CCM.0000000000005626. Epub 2022 Jul 21. | |
| 33328261 | Derived | Fuller BM, Roberts BW, Mohr NM, Pappal RD, Stephens RJ, Yan Y, Carpenter C, Kollef MH, Avidan MS. A study protocol for a multicentre, prospective, before-and-after trial evaluating the feasibility of implementing targeted SEDation after initiation of mechanical ventilation in the emergency department (The ED-SED Pilot Trial). BMJ Open. 2020 Dec 16;10(12):e041987. doi: 10.1136/bmjopen-2020-041987. |
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Sharing of data generated by this trial is an important part of the proposed activities. Data will be shared with other investigators through academically established means, as necessary and appropriate. Datasets generated from the trial will be available from the overall study principal investigator on reasonable request. Collaboration with others investigators is encouraged. The results will be disseminated via publication in a peer-reviewed journal and presentation at national meetings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Before Group | Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation Standard post intubation sedation practices: Usual care sedation provide in the ED |
| FG001 | After Group | Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Before Group | Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation Standard post intubation sedation practices: Usual care sedation provide in the ED |
| BG001 |
| 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 | Participant Recruitment | Count of eligible participants included in study | These numbers reflect the number of eligible participants who were included in the study for analysis (i.e. the final study population). As mentioned above in "Participant Flow", there were 1771 participants assessed for eligibility and 1356 were not eligible for the study. Therefore, the overall number of participants analyzed (i.e. 415) relects this. | Posted | Count of Participants | Participants | Through study completion, an average of 1 year |
|
Serious adverse events related to care in the emergency department were collected up to 12 hours (during mechanical ventilation in the emergency department). These were reported as outcomes and include: inadvertent extubation, device removal, and awareness with paralysis. All-cause mortality was collected up to 28 days, or for the duration of hospitalization. Other (Not Including Serious) Adverse Events were collected up to 28 days, or for the duration of the hospitalization.
Serious adverse events related to care in the emergency department were collected up to 12 hours (during mechanical ventilation in the emergency department). These were reported as outcomes and include inadvertent extubation, device removal, and awareness with paralysis.
All-cause mortality was collected up to 28 days, or for the duration of hospitalization.
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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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 | Before Group | Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation Standard post intubation sedation practices: Usual care sedation provide in the ED |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inadvertent extubation, device removal, awareness with paralysis | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian M Fuller | Washington Univeristy | 3147475368 | fullerb@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2021 | Oct 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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This is a prospective, before-and-after study, and there will be no randomization process.
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|
| Standard post intubation sedation practices | Other | Usual care sedation provide in the ED |
|
To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days. |
| Up to 28 days |
| Hospital-free Days | To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days. | Up to 28 days |
| Number of Participants With Delirium | Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care. | Up to 7 days |
| Mortality | Hospital mortality | Up to 28 days, or for the duration of hospitalization |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Cooper University Hospital/Cooper Medical School of Rowan University | Camden | New Jersey | 08103 | United States |
| After Group |
Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| After Group |
Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols. |
|
|
| Primary | Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range | Deep sedation defined as RASS of -3 to -5 Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable | Posted | Count of Participants | Participants | Up to 12 hours (during mechanical ventilation in the emergency department) |
|
|
|
| Primary | Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED | Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers. | Reliability of RASS assessments was only assessed in the after group as an assurance that the protocol was being effectively implemented and RASS measured appropriately | Posted | Number | 95% Confidence Interval | ICC | Up to 12 hours (during mechanical ventilation in the emergency department) |
|
|
|
| Primary | Number of Participants With Adverse Events | Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events | Posted | Count of Participants | Participants | Up to 12 hours (during mechanical ventilation in the emergency department) |
|
|
|
| Secondary | Ventilator-free Days | To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days. | Posted | Mean | Standard Deviation | days | Up to 28 days |
|
|
|
| Secondary | ICU-free Days | To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days. | Posted | Mean | Standard Deviation | days | Up to 28 days |
|
|
|
| Secondary | Hospital-free Days | To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days. | Posted | Mean | Standard Deviation | days | Up to 28 days |
|
|
|
| Secondary | Number of Participants With Delirium | Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care. | We recognize that the Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The numbers analyzed for delirium reflect the fact that some patients either died or were discharged and therefore not eligible to be assessed for delirium during the time frame. | Posted | Count of Participants | Participants | Up to 7 days |
|
|
|
| Secondary | Mortality | Hospital mortality | Posted | Count of Participants | Participants | Up to 28 days, or for the duration of hospitalization |
|
|
|
| 40 |
| 196 |
| 8 |
| 196 |
| 0 |
| 196 |
| EG001 | After Group | Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED Education: Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols. | 22 | 219 | 11 | 219 | 0 | 219 |
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| D013568 | Pathological Conditions, Signs and Symptoms |