Shortness of BreathNCT05649891
Checklists Resuscitation Emergency Department
A study testing Emergency Manual in people with Shortness of Breath and Chest Pain, run by Region Skane.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shortness of Breath, Chest Pain, Abdominal Pain
- What is being tested?
- Emergency Manual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Mar 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shortness of Breath, Chest Pain, Abdominal Pain, Altered Mental Status, Syncope, Seizures
- Being tested
- Emergency Manual
- Medical subject headings
- Dyspnea, Chest Pain, Abdominal Pain, Syncope, Seizures, Vertigo, Wounds and Injuries, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency ManualOther
Collection of crisis checklists and fact sheets
| Study group | Role | What they receive |
|---|---|---|
| Patients managed with Emergency Manual access | Experimental | Consecutive priority 1 patients managed by resuscitation teams with access to an Emergency Manual Receives: Other: Emergency Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of indication of interventions performed thanks to Do-Confirm Emergency Manual use
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.
Measured: 1 hour
Secondary outcomes (3)
Team's subjective evaluation of Emergency Manual value
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.
Measured: 1 hour
Degree of indication of interventions that might have been performed had the Emergency Manual been used
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.
Measured: 1 hour
Structured interviews
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:
- patient age, sex, presenting complaint and suspected diagnosis
- seniority of the physician initially in charge of the case
- events or concerns relating to EM use
- mode of EM use (Do-Confirm, Read-Do, Sampling) and sections relevant to the case
- personnel's assessment of the impact of the EM on patient care
- personnel's assessment of impact of the EM on team members and teamwork
- personnel's suggestions for EM improvement
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study startSep 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shortness of BreathStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Dryver, MD, Principal investigator, Skane's University Hospital in Lund, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649891
- Sponsor's protocol ID
- 2022-01896-01
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dryver E, Olsson de Capretz P, Mohammad M, Armelin M, Dupont WD, Bergenfelz A, Ekelund U. Clinical use of an emergency manual by resuscitation teams and impact on performance in the emergency department: a prospective mixed-methods study protocol. BMJ Open. 2023 Oct 17;13(10):e071545. doi: 10.1136/bmjopen-2022-071545.
PubMed 37848292
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of an Emergency Manual by Resuscitation Teams and Impact on Performance in the Emergency Department
- ClinicalTrials.gov ID
- NCT05649891
- Acronym / sponsor ID
- 2022-01896-01
- Conditions
- Shortness of Breath, Chest Pain, Abdominal Pain, Altered Mental Status, Syncope, Seizures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Dec 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients managed with Emergency Manual access | Experimental | Other: Emergency ManualConsecutive priority 1 patients managed by resuscitation teams with access to an Emergency Manual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Emergency ManualCollection of crisis checklists and fact sheets | Other | Patients managed with Emergency Manual access |
Primary outcome
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.
3 secondary outcomes
Team's subjective evaluation of Emergency Manual value
Time frame: 1 hour
Degree of indication of interventions that might have been performed had the Emergency Manual been used
Time frame: 1 hour
Structured interviews
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 37848292Dryver E, Olsson de Capretz P, Mohammad M, Armelin M, Dupont WD, Bergenfelz A, Ekelund U. Clinical use of an emergency manual by resuscitation teams and impact on performance in the emergency department: a prospective mixed-methods study protocol. BMJ Open. 2023 Oct 17;13(10):e071545. doi: 10.1136/bmjopen-2022-071545.
- 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.
Eric Dryver, MD principal investigator
Skane's University Hospital in Lund, Emergency Department
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Manual in people with Shortness of Breath and Chest Pain, run by Region Skane.
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 1 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 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Eric Dryver, MD (+46-738-198261, eric.dryver@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of indication of interventions performed thanks to Do-Confirm Emergency Manual use (time frame: 1 hour). 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 NCT05649891, which also lists 1 linked publication.
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 14 Dec 2022.