NCT05185596

Brief Summary

This study shall investigate the feasibility of prehospital performed trans-esophageal echocardiography in out of hospital cardiac arrest. The investigators will include ten patients undergoing advanced life support in this study and determine if it is possible to acquire adequate trans-esophageal images within 10 minutes after arrival of the study team on scene.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 8, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

December 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

December 8, 2021

Last Update Submit

December 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to obtain images of the heart

    Time from arrival of the study team on scene, until the following questions are answered by trans esophageal echocardiography: "is spontaneous cardiac movement present", "how ist LV function", "how is RV function", "is a pericardial effusion or tamponade present". The time will be measured in seconds and a maximum of 600 seconds is allowed. If answering the questions within 600 seconds is possible, the case will be counted as "feasible" and the duration of the time measured will be recorded. If answering the questions takes longer than 10 minutes, the case will be counted as "not feasible"

    10 minutes

Secondary Outcomes (4)

  • Hands off times

    10 minutes

  • Hindering of advanced life support measures

    10 minutes

  • Trans esophageal echocardiography related complications

    10 minutes

  • Image quality

    10 minutes

Study Arms (1)

Trans-esophageal echocardiography

EXPERIMENTAL

Transesophageal Echocardiography during advanced life support for out of hospital cardiac arrest will be performed.

Device: Transesophageal Echocardiography

Interventions

transesophageal Echocardiography during advanced life support

Trans-esophageal echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing advanced life support for out of hospital cardiac arrest

You may not qualify if:

  • patients who should undergo rapid transport to the hospital with ongoing CPR (ECMO candidates, pregnant, trauma, obvious reversible which can be treated in hospital only)
  • known esophageal pathology contraindicating TEE
  • no definite secure airway present (endotracheal intubation, tracheostomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Thomas Hamp, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 11, 2022

Study Start

December 11, 2021

Primary Completion

July 31, 2022

Study Completion

August 31, 2022

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations