NCT05649891

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

November 21, 2022

Last Update Submit

December 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 hour

Secondary Outcomes (3)

  • Team's subjective evaluation of Emergency Manual value

    1 hour

  • Degree of indication of interventions that might have been performed had the Emergency Manual been used

    1 hour

  • Structured interviews

    Up to 8 weeks

Study Arms (1)

Patients managed with Emergency Manual access

EXPERIMENTAL

Consecutive priority 1 patients managed by resuscitation teams with access to an Emergency Manual

Other: Emergency Manual

Interventions

Collection of crisis checklists and fact sheets

Patients managed with Emergency Manual access

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DyspneaChest PainAbdominal PainSyncopeSeizuresVertigoWounds and InjuriesHypersensitivityFeverHeart ArrestPneumoniaBradycardiaTachycardiaShockBurnsPoisoningDiabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms, DigestiveUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNervous System DiseasesVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesImmune System DiseasesBody Temperature ChangesHeart DiseasesCardiovascular DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesArrhythmias, CardiacPathologic ProcessesCardiac Conduction System DiseaseChemically-Induced DisordersKetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Eric Dryver, MD

    Skane's University Hospital in Lund, Emergency Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulf Ekelund, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 14, 2022

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share