Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04810520
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in emergency medicine for diagnosis and treatment of reversible causes. However, in prehospital setting performing ultrasound and the translation of the findings can be challenging. As new prehospital ultrasound devices offer the possibility for remote supervision, the impact of tele-supervision on time to diagnosis of critically ill patients is unclear.

Aims: The aim of this study is to evaluate the impact of tele-supervision on the time of POCUS in prehospital critically ill patients by air rescue physicians.

Methods: In total 100 critically ill patients suffering from acute dyspnoea, circulatory failure or trauma, which are treated by air rescue physicians will be included in this study. Duration of ultrasound performance as well as altered treatment strategies will be analyzed.

Condition or Disease	Intervention/Treatment	Phase
Echocardiography; Telemedicine	Other: Point-of-care ultrasound with tele-supervision; Other: Point-of-care ultrasound without tele-supervision

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Point-of-care ultrasound with tele-supervision Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.	Other: Point-of-care ultrasound with tele-supervision; Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.
Point-of-care ultrasound without tele-supervision Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed without tele-supervision.	Other: Point-of-care ultrasound without tele-supervision; Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.

Outcome Measures

Primary Outcome Measures

1. Duration of prehospital ultrasound between POCUS with or without tele-supervision [through study completion, an average of 1 year]

   duration of prehospital ultrasound between POCUS with tele-supervision and POCUS without tele-supervision in critically ill patients (acute dyspnoea, circulatory failure, trauma).

Secondary Outcome Measures

1. Alteration of treatent strategies [through study completion, an average of 1 year]

   Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on alteration of treatment strategies.

Other Outcome Measures

1. Accuracy of suspected diagnosis in comparison to clinical findings [through study completion, an average of 1 year]

   Investigating the impact of POCUS with tele-supervision in comparison to POCUS without tele-supervision on accuracy of suspected diagnosis in comparison to clinical findings.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Critically ill patients suffering from acute dyspnoea, circulatory failure or trauma will be included.

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

• Respiratory rate > 20 breaths per minute

• Peripheral oxygen saturation without oxygen supplementation < 90%

Patients with acute circulatory failure will be included, if they show at least one of the following signs:

• Hypotension (systolic blood pressure <90mmHg)

• Altered tissue perfusion (cold, clammy, mottling skin or altered mental status)

Trauma patients will be included, if at least one cause is suspected:

• Intraabdominal fluid

• Intrathoracic free fluid

• Pneumothorax

Exclusion Criteria:

• age under 18

• if POCUS will lead to a delay of live-saving treatment or transportation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Anaesthesia & General Intensive Care	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Study Chair: Department of Anaesthesia & General Intensive Care, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christina Hafner, Clinical Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT04810520
• Other Study ID Numbers: 1218/2021
• First Posted: Mar 23, 2021
• Last Update Posted: Jan 14, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christina Hafner, Clinical Investigator, Medical University of Vienna: Ultrasound diagnostics; Prehospital emergency medicine

Study Results

No Results Posted as of Jan 14, 2022