Point-of-care Ultrasound in Prehospital Dyspnea

Dyspnea Clinical Trial

Official title:

Point-of-care Ultrasound in Prehospital Dyspnea: Game-changer or Gaming-gadgets?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03905460
• Other study ID #: POC Ultrasound
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• trama patients
• prior enrollment

Related Conditions & MeSH terms

• Dyspnea

Intervention

Diagnostic Test:
• Point-of-care ultrasound
Focused ultrasound of the heart, lungs and pleurae

Locations

Country	Name	City	State
Denmark	Præhospitalet	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity, clinical exam	Sensitivity of clinical examination for for diagnosing heart failure. Held up against a post-hoc expert panel statement.	From initial citizen contact and within a time-span of 15 minutes
Secondary	Sensitivity, Ultrasound examination	Sensitivity of clinical examination supplemented with ultrasound scan for diagnosing heart failure. Held up against a post-hoc expert panel statement.	From initial citizen contact and within a time-span of 15 minutes
Secondary	Treatment changes in medicine caused by ultrasound examination	Changes in medical treatment including diuretics, nitric oxide, bronkodilation and steroids caused by the addition of an ultrasound scan	From initial citizen contact and within a time-span of 15 minutes
Secondary	Treatment changes in ventilation caused by ultrasound examination	Treatment changes ventilatory strategy including nasal cannula oxygen therapi, face mask or non-invasive positive pressure ventilation caused by the addition of an ultrasound scan	From initial citizen contact and within a time-span of 15 minutes
Secondary	Triage changes caused by ultrasound examination	Change in the department or hospital that the patient is sent to as a cause of an ultrasound scan	From initial citizen contact and within a time-span of 60 minutes