Clinical trial NCT04817488: Live Stream of Prehospital Emergency Ultrasound in Patients with Acute Dyspnoea
Official title: Live Stream of Prehospital Emergency Ultrasound in Patients with Acute Dyspnoea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Echocardiography
Acute Dyspnea
Keywords: Ultrasound diagnostics
Prehospital emergency medicine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 350 critically ill patients with acute dyspnoea will be included in this study. In 175 patients ultrasound with tele-supervision and in 175 patients ultrasound without tele-supervision will be performed. Allocation to one of the two groups depends on the availability of tele-supervision. Tele-supervision is available in 50% of the time.

Brief summary: Background: Acute dyspnoea is a common symptom in prehospital emergency medicine. As ultrasound gained in importance for diagnosis in patients with acute respiratory distress, it plays even a role in the prehospital setting. However, prehospital emergency ultrasound (PEU) remains challenging and requires knowledge and skills. New prehospital ultrasound devices offer the possibility for tele-supervision. The impact of tele-supervision of PEU in patients with acute dyspnoea is unclear.

Objective: This prospective observational study aims to evaluate the effect of PEU with tele-supervision on diagnosis, treatment strategies and cognitive load in comparison to PEU without tele-supervision in patients with acute dyspnoea.

Methods: In total 350 prehospital emergency patients with acute dyspnoea will be included in this study. Patients will be observed in two groups. In group 1 PEU will be performed with tele-supervision, whereas in group 2 PEU will be performed without tele-supervision (tele-supervision not available).


Eligibility criteria: Inclusion Criteria:

Patients will be included, if they suffer from acute dyspnoea and at least one of the two following signs of respiratory failure:

* Respiratory rate \>20 breaths per minute
* Peripheral oxygen saturation without oxygen supplementation \<90%

Exclusion Criteria:

* under the age of 18
* if PEU will lead to a delay of live-saving treatment or transportation
* if patient rejects the PEU, the patient will be excluded

Primary outcomes:
measure: Accuracy of prehospital diagnosis after PEU in relation to the (correct) in-hospital diagnosis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Agreement of diagnosis before PEU and after PEU
timeFrame: through study completion, an average of 1 year
measure: Duration of prehospital emergency ultrasound (PEU)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Anaesthesia & General Intensive Care
Study officials:
affiliation: Medical University of Vienna
name: Department of Anaesthesia & General Intensive Care
role: STUDY_CHAIR
References: