Conscious SedationNCT04172415
Current Procedural Sedation Practices in a Canadian Community Emergency Department
An observational study of Conscious Sedation, run by Amber Graystone at 1 site in Canada.
Trial summary
To review current Emergency Department procedural sedation practices in the community hospital setting and the associated drugs used (class of anesthetic and mode of administration). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Retrospective cohort
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who have registered in the Welland County General Hospital Emergency Department (WHS) from the dates of January 2017 -December 2018 and require procedural sedation.
Who may be able to join
- patients who have registered in the Welland County General Hospital Emergency Department (WHS) from the dates of January 2017-December 2018.
- Patients who require procedural sedation in the Emergency Department
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Current Procedural Sedation Practices for Adults and Children in a Canadian Community Emergency Department
To review current Emergency Department procedural sedation practices in the community hospital setting and the associated drugs used (class of anesthetic and mode of administration). The ultimate goal of this investigation is to determine the need for a new analgesic/anesthesia drug and to compare the outcomes of a new drug within the same community Emergency Department setting. In particular, this may present a future opportunity to evaluate Penthrox (methoxyflurane) as a viable alternative for procedural sedation and analgesia in Canadian Emergency Departments.
Read the detailed description
Procedural sedation is a common practice in the Emergency Department setting. The purpose of procedural sedation is to provide adequate pain relief to patients undergoing an emergent procedure. As a result, the time to the patient's symptom relief, the degree of side effects and the duration of action of the medication are all critical to selecting an appropriate sedative and/or analgesic.
The community hospital setting may present unique challenges to successfully administering procedural sedation techniques. Funding and resource allocation can limit patient access to timely sedation/analgesia. This can be compounded by prolonged stays in the Emergency Department for recovery and/or complications.
The current recommendations for 'Procedural Sedation and Analgesia in the Emergency Department' outlines recommended medications and policies for adults and children undergoing procedural sedation1,2. While a number of cohort and retrospective analyses have been done in a variety of research settings, the role for oral or intranasal anesthesia has not been adequately explored in ED settings. The initial phase of this research proposal will identify current local practices through chart review analysis collected over the last year. Subsequent research questions might include a comparative analysis of the current procedural sedation techniques compared to medications administered orally or by inhalation. This may have considerable future benefit to patient satisfaction and clinical outcomes, as well as resource and operational outcomes in the Emergency Department.
Hypothesis
To identify interventions requiring procedural sedation and the medication commonly used in a Canadian community emergency department (ED). Using standardized medical record review methods, primary clinical patient indicators, safety outcomes and secondary ED operational outcomes will be reviewed.3
Study Design
This retrospective chart review will be obtained from data of patients who have registered in the Welland County General Hospital (WHS) from the dates of January 2017 -December 2018. This timeframe should capture a sample size of ~300 patients.
Patients will be included in our study if they have received conscious sedation for a diagnostic or therapeutic procedure in the emergency department. They will be identified through review of billing records for anesthesia codes. Medical records, specifically physician procedural sedation records and nursing documentation, will be our main resources for data extraction. The investigators will describe and quantify the procedures requiring conscious sedation and identify the medication (and route) used, using a standardized data abstraction tool to be created from international ED PSA guidelines.1,2 Primary outcome measures will include ED PSA indications, pre-procedural assessments (medical comorbidities, difficult airway predictors, other safety factors), medications used, sedation failures/use of rescue medications, procedural successes or failures, post-PSA assessments, PSA recovery and patient disposition. Further stratification by age and other demographic features will help us better understand trends between the adult and pediatric population.
Patients requiring anaesthesia for the purpose of intubation and ventilator support will be excluded from this study.
Our secondary outcomes involve resource utilization and complications. Duration of procedure and time to discharge will be measured. Data on adverse outcomes and unplanned admission rates will also be collected. Adverse outcomes of interest will be vomiting, medication for blood pressure support, dysrhythmias, unanticipated intubation, laryngospasm, pulse oximetry less than 90%, apnea requiring bag-valve-mask ventilation and death.
- Conditions
- Conscious Sedation
- Being tested
- Retrospective cohort
- Keywords
- Procedural Sedation, Chart Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective cohortOther
Chart Review
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patients that received procedural sedation in a community Emergency Department. Receives: Other: Retrospective cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Sedation
Total number of patients requiring conscious sedation
Measured: 2 years
Medication Use
The number and type of medications used during procedure
Measured: 2 years
Pre Procedural Assessment Findings
ASA score, 3-3-2 Abnormality, Pre-procedure Fast, Mallampatie Class, Neck Obesity, Facial Hair
Measured: 2 years
Sedation Failures and Use of Rescue Medications
Number of occurrences where sedation is inadequate for treatment and number/type of rescue medication used to achieve adequate sedation
Measured: 2 years
Time of Discharge
Time of patient discharge or transfer from Emergency Department
Measured: 2 years
Secondary outcomes (5)
Length of time spent in Emergency Department
Measured: 2 years
Duration of Procedure and Time to discharge
Measured: 2 years
Number of Adverse Outcomes
Measured: 2 years
Rate of Hospital Admission
Measured: 2 years
Time from Triage to initiation of procedural sedation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start30 Nov 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amber Graystone
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor-investigator, Amber Graystone, Niagara Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172415
- Sponsor's protocol ID
- 7148-C
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Procedural Sedation Practices for Adults and Children in a Canadian Community Emergency Department
- ClinicalTrials.gov ID
- NCT04172415
- Acronym / sponsor ID
- 7148-C
- Conditions
- Conscious Sedation
- Keywords
- Procedural Sedation, Chart Review
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Amber GraystoneUniversity, hospital or other
- Collaborators
- Purdue Pharma LP
- Study start
- 30 Nov 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To review current Emergency Department procedural sedation practices in the community hospital setting and the associated drugs used (class of anesthetic and mode of administration). The ultimate goal of this investigation is to determine the need for a new analgesic/anesthesia drug and to compare the outcomes of a new drug within the same community Emergency Department setting. In particular, this may present a future opportunity to evaluate Penthrox (methoxyflurane) as a viable alternative for procedural sedation and analgesia in Canadian Emergency Departments.
Detailed description
Procedural sedation is a common practice in the Emergency Department setting. The purpose of procedural sedation is to provide adequate pain relief to patients undergoing an emergent procedure. As a result, the time to the patient's symptom relief, the degree of side effects and the duration of action of the medication are all critical to selecting an appropriate sedative and/or analgesic.
The community hospital setting may present unique challenges to successfully administering procedural sedation techniques. Funding and resource allocation can limit patient access to timely sedation/analgesia. This can be compounded by prolonged stays in the Emergency Department for recovery and/or complications.
The current recommendations for 'Procedural Sedation and Analgesia in the Emergency Department' outlines recommended medications and policies for adults and children undergoing procedural sedation1,2. While a number of cohort and retrospective analyses have been done in a variety of research settings, the role for oral or intranasal anesthesia has not been adequately explored in ED settings. The initial phase of this research proposal will identify current local practices through chart review analysis collected over the last year. Subsequent research questions might include a comparative analysis of the current procedural sedation techniques compared to medications administered orally or by inhalation. This may have considerable future benefit to patient satisfaction and clinical outcomes, as well as resource and operational outcomes in the Emergency Department.
Hypothesis
To identify interventions requiring procedural sedation and the medication commonly used in a Canadian community emergency department (ED). Using standardized medical record review methods, primary clinical patient indicators, safety outcomes and secondary ED operational outcomes will be reviewed.3
Study Design
This retrospective chart review will be obtained from data of patients who have registered in the Welland County General Hospital (WHS) from the dates of January 2017 -December 2018. This timeframe should capture a sample size of ~300 patients.
Patients will be included in our study if they have received conscious sedation for a diagnostic or therapeutic procedure in the emergency department. They will be identified through review of billing records for anesthesia codes. Medical records, specifically physician procedural sedation records and nursing documentation, will be our main resources for data extraction. The investigators will describe and quantify the procedures requiring conscious sedation and identify the medication (and route) used, using a standardized data abstraction tool to be created from international ED PSA guidelines.1,2 Primary outcome measures will include ED PSA indications, pre-procedural assessments (medical comorbidities, difficult airway predictors, other safety factors), medications used, sedation failures/use of rescue medications, procedural successes or failures, post-PSA assessments, PSA recovery and patient disposition. Further stratification by age and other demographic features will help us better understand trends between the adult and pediatric population.
Patients requiring anaesthesia for the purpose of intubation and ventilator support will be excluded from this study.
Our secondary outcomes involve resource utilization and complications. Duration of procedure and time to discharge will be measured. Data on adverse outcomes and unplanned admission rates will also be collected. Adverse outcomes of interest will be vomiting, medication for blood pressure support, dysrhythmias, unanticipated intubation, laryngospasm, pulse oximetry less than 90%, apnea requiring bag-valve-mask ventilation and death.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: Retrospective cohortPatients that received procedural sedation in a community Emergency Department. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have registered in the Welland County General Hospital Emergency Department (WHS) from the dates of January 2017 -December 2018 and require procedural sedation.
Key inclusion criteria (2 listed)
- patients who have registered in the Welland County General Hospital Emergency Department (WHS) from the dates of January 2017-December 2018.
- Patients who require procedural sedation in the Emergency Department
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Retrospective cohortChart Review | Other | Retrospective cohort |
Primary outcome
Procedural Sedation
Time frame: 2 years
Total number of patients requiring conscious sedation
Medication Use
Time frame: 2 years
The number and type of medications used during procedure
Pre Procedural Assessment Findings
Time frame: 2 years
ASA score, 3-3-2 Abnormality, Pre-procedure Fast, Mallampatie Class, Neck Obesity, Facial Hair
Sedation Failures and Use of Rescue Medications
Time frame: 2 years
Number of occurrences where sedation is inadequate for treatment and number/type of rescue medication used to achieve adequate sedation
Time of Discharge
Time frame: 2 years
Time of patient discharge or transfer from Emergency Department
5 secondary outcomes
Length of time spent in Emergency Department
Time frame: 2 years
Duration of Procedure and Time to discharge
Time frame: 2 years
Number of Adverse Outcomes
Time frame: 2 years
Rate of Hospital Admission
Time frame: 2 years
Time from Triage to initiation of procedural sedation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conscious Sedation, run by Amber Graystone at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
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?
Procedural Sedation (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2019.