NCT04817475

Brief Summary

Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in out-of-hospital cardiac arrest (OHCA) for diagnosis and treatment of reversible causes. However, in prehospital emergency medicine 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 the performance of POCUS during OHCA is unclear. Aims: This prospective observational study aims to evaluate if POCUS with tele-supervision can be performed during CPR without any additional hands-off periods longer than 5 seconds. Methods: In total 30 patients with OHCA, where POCUS is considered, will be included in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

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 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

March 23, 2021

Last Update Submit

October 25, 2023

Conditions

Cardiopulmonary ResuscitationEchocardiographyUltrasound

Keywords

Ultrasound diagnsticsPrehospital emergency medicineTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Hands-off time during prehospital cardiopulmonary resuscitation

    The primary outcome of this study evaluates, if POCUS with tele-supervision can be performed during prehospital cardiopulmonary resuscitation without any additional hands-off period longer than 5 seconds

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on the duration time of POCUS

    through study completion, an average of 1 year

  • Impact of real-time supervision of POCUS during cardiopulmonary resuscitation on changing of diagnosis of suspected cause of out-of-hospital cardiac arrest.

    through study completion, an average of 1 year

Study Arms (1)

Point-of-care ultrasound with tele-supervision

Point-of-care ultrasound of patients with a out-of-hospital cardiac arrest will be performed with tele-supervision.

Other: Point-of-care ultrasound with tele-supervision

Interventions

Point-of-care ultrasound with tele-supervisionOTHER

Point-of-care ultrasound of patients with a out-of-hospital cardiac arrest will be performed with tele-supervision.

Point-of-care ultrasound with tele-supervision

Eligibility Criteria

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

30 critically ill patients suffering from acute cardiopulmonary resuscitation will be included in this study. POCUS will be performed with tele-supervision.

You may qualify if:

  • Patients with prehospital cardiac arrest, where POCUS is considered during cardiac pulmonary resuscitation, will be included.

You may not qualify if:

  • under the age of 18,
  • if POCUS is not considered or if POCUS will lead to a delay of live-saving treatment or transportation.
  • pregnant patients
  • patients with a body-mass-index (BMI) above 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Anaesthesia & General Intensive Care

Vienna, 1090, Austria

Location

Related Publications (1)

  • Hafner C, Manschein V, Klaus DA, Schaubmayr W, Tiboldi A, Scharner V, Gleiss A, Thal B, Krammel M, Hamp T, Willschke H, Hermann M. Live stream of prehospital point-of-care ultrasound during cardiopulmonary resuscitation - A feasibility trial. Resuscitation. 2024 Jan;194:110089. doi: 10.1016/j.resuscitation.2023.110089. Epub 2023 Dec 16.

    PMID: 38110144DERIVED

Study Officials

  • Department of Anaesthesia & General Intensive Care

    Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

AU(1)