AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Canada1 site
  • Niagara Health

    St. Catharines, Ontario, L2S 0A9

Other trials in Canada

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.

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 groups in NCT04172415
Study groupRoleWhat they receive
Retrospective cohortPatients 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.

  1. Procedural Sedation

    Total number of patients requiring conscious sedation

    Measured: 2 years

  2. Medication Use

    The number and type of medications used during procedure

    Measured: 2 years

  3. Pre Procedural Assessment Findings

    ASA score, 3-3-2 Abnormality, Pre-procedure Fast, Mallampatie Class, Neck Obesity, Facial Hair

    Measured: 2 years

  4. 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

  5. Time of Discharge

    Time of patient discharge or transfer from Emergency Department

    Measured: 2 years

Secondary outcomes (5)
  1. Length of time spent in Emergency Department

    Measured: 2 years

  2. Duration of Procedure and Time to discharge

    Measured: 2 years

  3. Number of Adverse Outcomes

    Measured: 2 years

  4. Rate of Hospital Admission

    Measured: 2 years

  5. 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.

  1. First posted21 Nov 2019
  2. Study start30 Nov 2019 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completion1 Oct 2020 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in