Trial Outcomes & Findings for The Emergency Department Sedation Pilot Trial (NCT NCT04410783)
NCT ID: NCT04410783
Last Updated: 2022-12-28
Results Overview
Count of eligible participants included in study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1771 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2022-12-28
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
876
|
895
|
|
Overall Study
COMPLETED
|
196
|
219
|
|
Overall Study
NOT COMPLETED
|
680
|
676
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Emergency Department Sedation Pilot Trial
Baseline characteristics by cohort
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=113 Participants
|
134 Participants
n=163 Participants
|
254 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=113 Participants
|
84 Participants
n=163 Participants
|
158 Participants
n=160 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 18.4 • n=113 Participants
|
57.4 years
STANDARD_DEVIATION 18.3 • n=163 Participants
|
57.6 years
STANDARD_DEVIATION 18.3 • n=160 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=113 Participants
|
90 Participants
n=163 Participants
|
161 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=113 Participants
|
129 Participants
n=163 Participants
|
254 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
101 Participants
n=113 Participants
|
102 Participants
n=163 Participants
|
203 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
71 Participants
n=113 Participants
|
94 Participants
n=163 Participants
|
165 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
14 Participants
n=113 Participants
|
18 Participants
n=163 Participants
|
32 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=113 Participants
|
4 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
5 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
196 participants
n=113 Participants
|
219 participants
n=163 Participants
|
415 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: 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.
Count of eligible participants included in study
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
Participant Recruitment
|
196 Participants
|
219 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hours (during mechanical ventilation in the emergency department)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
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
|
118 Participants
|
85 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hours (during mechanical ventilation in the emergency department)Population: 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
Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.
Outcome measures
| Measure |
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
|
After Group
n=66 Participants
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.
|
|---|---|---|
|
Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED
|
—
|
0.88 ICC
Interval 0.82 to 0.93
|
PRIMARY outcome
Timeframe: Up to 12 hours (during mechanical ventilation in the emergency department)Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysTo 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.
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
Ventilator-free Days
|
19.9 days
Standard Deviation 10.6
|
22.0 days
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Up to 28 daysTo 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.
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
ICU-free Days
|
18.1 days
Standard Deviation 10.4
|
20.8 days
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Up to 28 daysTo 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.
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
Hospital-free Days
|
14.3 days
Standard Deviation 10.1
|
15.2 days
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: 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.
Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.
Outcome measures
| Measure |
Before Group
n=167 Participants
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
|
After Group
n=198 Participants
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.
|
|---|---|---|
|
Number of Participants With Delirium
|
63 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days, or for the duration of hospitalizationHospital mortality
Outcome measures
| Measure |
Before Group
n=196 Participants
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
|
After Group
n=219 Participants
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.
|
|---|---|---|
|
Mortality
|
40 Participants
|
22 Participants
|
Adverse Events
Before Group
Serious events: 8 serious events
Other events: 0 other events
Deaths: 40 deaths
After Group
Serious events: 11 serious events
Other events: 0 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Before Group
n=196 participants at risk
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
|
After Group
n=219 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Inadvertent extubation, device removal, awareness with paralysis
|
4.1%
8/196 • 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.
|
5.0%
11/219 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place