Mechanical VentilationED SED PilotNCT04410783
The Emergency Department Sedation Pilot Trial
A study testing Education and Standard post intubation sedation practices in people with Mechanical Ventilation and Respiratory Failure, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Respiratory Failure
- What is being tested?
- Education and Standard post intubation sedation practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,771 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Sep 2020to 28 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation via an endotracheal tube.
- Age ≥ 18 years.
Who cannot join
- Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, status epilepticus, fulminant hepatic failure).
- Ongoing neuromuscular blockade.
- Death or transition to comfort measures within 24 hours.
- Transfer to another hospital from the ED.
- Chronic/home mechanical ventilation.
- Transfer directly from the ED to the operating room.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cooper University Hospital/Cooper Medical School of Rowan University
Camden, New Jersey, 08103
University of Iowa
Iowa City, Iowa, 52242
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department
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.
Read the detailed description
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.
- Conditions
- Mechanical Ventilation, Respiratory Failure
- Being tested
- Education, Standard post intubation sedation practices
- Keywords
- Sedation, Mechanical Ventilation, Emergency Department, RASS
- Medical subject headings
- Respiratory Insufficiency, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
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.
Standard post intubation sedation practicesOther
Usual care sedation provide in the ED
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standard post intubation sedation practices |
| After group | Other | Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment
Count of eligible participants included in study
Measured: 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
Measured: 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.
Measured: 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
Measured: Up to 12 hours (during mechanical ventilation in the emergency department)
Secondary outcomes (5)
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.
Measured: Up to 28 days
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.
Measured: 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.
Measured: Up to 28 days
Number of Participants With Delirium
Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.
Measured: Up to 7 days
Mortality
Hospital mortality
Measured: Up to 28 days, or for the duration of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start14 Sep 2020
- Primary completion28 May 2022
- Study completion28 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a prospective, before-and-after study, and there will be no randomization process.
- Masking
- None (open label)
- Enrolment
- 1,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Cooper University Health Care, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Brian Fuller, Washington University School of Medicine
- Investigators
- Brian Fuller, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410783
- Sponsor's protocol ID
- 201909100
- Other IDs
- R34HL150404
- Acronym
- ED SED Pilot
- Status last verified
- Dec 2022
- First submitted
- 20 May 2020
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35866657Fuller 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.
PubMed 33328261
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department
- ClinicalTrials.gov ID
- NCT04410783
- Acronym / sponsor ID
- ED SED Pilot / 201909100
- Conditions
- Mechanical Ventilation, Respiratory Failure
- Keywords
- Sedation, Mechanical Ventilation, Emergency Department, RASS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,771 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Iowa, Cooper University Health Care, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, before-and-after study, and there will be no randomization process.
| Arm | Type | Receives |
|---|---|---|
| Before group | Other | Other: Standard post intubation sedation practicesMechanically 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 | Behavioral: EducationMechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical ventilation via an endotracheal tube.
- Age ≥ 18 years.
Key exclusion criteria (6 listed)
- Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, status epilepticus, fulminant hepatic failure).
- Ongoing neuromuscular blockade.
- Death or transition to comfort measures within 24 hours.
- Transfer to another hospital from the ED.
- Chronic/home mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationNurses 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. | Behavioural | After group |
| Standard post intubation sedation practicesUsual care sedation provide in the ED | Other | Before group |
Primary outcome
Participant Recruitment
Time frame: Through study completion, an average of 1 year
Count of eligible participants included in study
Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
Time frame: 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
Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.
Number of Participants With Adverse Events
Time frame: 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
5 secondary outcomes
Ventilator-free Days
Time frame: Up to 28 days
ICU-free Days
Time frame: Up to 28 days
Hospital-free Days
Time frame: Up to 28 days
Number of Participants With Delirium
Time frame: Up to 7 days
Mortality
Time frame: Up to 28 days, or for the duration of hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35866657Fuller 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.
- Derived from this study: PubMed 33328261Fuller 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Fuller, MD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Standard post intubation sedation practices in people with Mechanical Ventilation and Respiratory Failure, run by Washington University School of Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.