- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649891
Checklists Resuscitation Emergency Department
December 5, 2022 updated by: Region Skane
Clinical Use of an Emergency Manual by Resuscitation Teams and Impact on Performance in the Emergency Department
The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.
Study Overview
Status
Not yet recruiting
Conditions
- Pneumonia
- Burns
- Shock
- Poisoning
- Abdominal Pain
- Chest Pain
- Trauma
- Fever
- Bradycardia
- Syncope
- Seizures
- Vertigo
- Tachycardia
- Cardiac Arrest
- Diabetic Ketoacidosis
- Shortness of Breath
- Allergic Reaction
- Asthma Acute
- Altered Mental Status
- COPD Exacerbation Acute
- Pulmonary Edema - Acute
- Hyperglycemic Hyperosmolar Nonketotic Syndrome
Intervention / Treatment
Detailed Description
Simulation-based studies indicate that crisis checklist use improves management of patients with critical conditions in the emergency department (ED).
This six-month-long study prospectively evaluates a digital emergency manual-a collection of crisis checklists and fact sheets-during the management of priority 1 patients in the Skåne University Hospital at Lund's ED.
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric Dryver, MD
- Phone Number: +46-738-198261
- Email: eric.dryver@med.lu.se
Study Contact Backup
- Name: Ulf Ekelund, MD PhD
- Phone Number: +46-702-049480
- Email: ulf.ekelund@med.lu.se
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients managed with Emergency Manual access
Consecutive priority 1 patients managed by resuscitation teams with access to an Emergency Manual
|
Collection of crisis checklists and fact sheets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of indication of interventions performed thanks to Do-Confirm Emergency Manual use
Time Frame: 1 hour
|
The primary outcome measures are the proportions of interventions performed thanks to Do-Confirm EM use graded as indicated, of neutral relevance, and not indicated.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Team's subjective evaluation of Emergency Manual value
Time Frame: 1 hour
|
The team's subjective evaluation of the EM's value is recorded prior to the logging out from the EM using a Likert scale of 1 to 6.
|
1 hour
|
|
Degree of indication of interventions that might have been performed had the Emergency Manual been used
Time Frame: 1 hour
|
Fifty patients that presented during the six-month period preceding EM implementation, are identified.
These 50 patients are selected based on matching to the 50 patients where the EM was used, using age, presenting complaint and relevant co-morbidities.
In addition, fifty patients where the EM was not used during the pilot study period are also identified based on the same matching process.
The EM is accessed to determine whether additional interventions would have been performed, had the EM been used.
All interventions-those actually performed as well as those that might have been performed had the EM been used-are then assessed for degree of indication by three external reviewers.
|
1 hour
|
|
Structured interviews
Time Frame: Up to 8 weeks
|
Teams can electronically request contact with the investigators to report specific events related to EM use. If so, the following data is extracted during a structured interview:
|
Up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Dryver, MD, Skane's University Hospital in Lund, Emergency Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2023
Primary Completion (Anticipated)
March 1, 2024
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
December 5, 2022
First Posted (Actual)
December 14, 2022
Study Record Updates
Last Update Posted (Actual)
December 14, 2022
Last Update Submitted That Met QC Criteria
December 5, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Respiration Disorders
- Lung Diseases
- Pain
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Endocrine System Diseases
- Disease Attributes
- Signs and Symptoms, Digestive
- Diabetes Complications
- Diabetes Mellitus
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Signs and Symptoms, Respiratory
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Vestibular Diseases
- Unconsciousness
- Consciousness Disorders
- Acid-Base Imbalance
- Acidosis
- Hypersensitivity
- Emergencies
- Poisoning
- Chest Pain
- Abdominal Pain
- Bradycardia
- Seizures
- Vertigo
- Tachycardia
- Syncope
- Pulmonary Edema
- Dyspnea
- Ketosis
- Diabetic Ketoacidosis
Other Study ID Numbers
- 2022-01896-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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