NCT03905460

Brief Summary

Point-of-care ultrasound in patients with dyspnoea has been shown to alter patient treatment and the time to correct treatment when performed in emergency departments. In Denmark, physician-staffed ambulances are sent to citizens with severe ABCD symptoms including dyspnoea. Hence, there is a potential for correct diagnostics and appropriate treatment already in the citizens' own home or en route to the hospital. This study aims to evaluate the clinical performance of prehospital point-of-care ultrasound in patients with dyspnoea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

2.6 years

First QC Date

March 21, 2019

Last Update Submit

November 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity for diagnosing heart failure

    Change in sensitivity for diagnosing heart failure when adding point-of-care ultrasound to the clinical examination

    From initial citizen contact to end of ultrasound examination within 15 minutes

Secondary Outcomes (5)

  • Sensitivity, clinical exam

    From initial citizen contact and within a time-span of 15 minutes

  • Sensitivity, Ultrasound examination

    From initial citizen contact and within a time-span of 15 minutes

  • Treatment changes in medicine caused by ultrasound examination

    From initial citizen contact and within a time-span of 15 minutes

  • Treatment changes in ventilation caused by ultrasound examination

    From initial citizen contact and within a time-span of 15 minutes

  • Triage changes caused by ultrasound examination

    From initial citizen contact and within a time-span of 60 minutes

Interventions

Focused ultrasound of the heart, lungs and pleurae

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All citizens who have contacted the Acute Medical Coordination center in the Central Denmark Region for emergency medical treatment.

You may qualify if:

  • age \>/= 18 years
  • dyspnea as a dominating complaint At least one of
  • respiratory frequency \>25/minute
  • oxygen saturation \< 95%
  • oxygen therapy initiated

You may not qualify if:

  • trama patients
  • prior enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Præhospitalet

Aarhus, Denmark

Location

Related Publications (1)

  • Gundersen EA, Juhl-Olsen P, Bach A, Rostgaard-Knudsen M, Nielsen BRR, Skaarup SH, Petersen HO, Fjolner J, Poulsen MGG, Botker MT. PrehospitaL Ultrasound in Undifferentiated DyspnEa (PreLUDE): a prospective, clinical, observational study. Scand J Trauma Resusc Emerg Med. 2023 Feb 5;31(1):6. doi: 10.1186/s13049-023-01070-4.

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Morten Bøtker, MD, Phd

    Prehospital of Central Denmark Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2019

First Posted

April 5, 2019

Study Start

May 15, 2019

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations