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Prehospital TEE in Cardiac Arrest

Primary Purpose

Echocardiography, Transesophageal, Out-of-Hospital Cardiac Arrest

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Transesophageal Echocardiography
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Echocardiography, Transesophageal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trans-esophageal echocardiography

Arm Description

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

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

Hands off times
what are the "hands off times" (defined as time during which no chest compressions are performed during the resuscitation) during ALS with or without TEE.
Hindering of advanced life support measures
The number of events that hinder the established advanced life support measures will be counted graded by severity (minimal, minor, major)
Trans esophageal echocardiography related complications
What complications are caused by trans esophageal echocardiography occur during ALS: displacement of the endotracheal tube, dental injury, pharyngeal injury
Image quality
How is image quality of trans esophageal echocardiography during advanced life support measures? This will be determined by the investigator performing the trans esophageal echocardiography and also by a blinded specialist afterwards. The rating will be "excellent", "good", "moderate", "poor", "extremely poor"

Full Information

First Posted
December 8, 2021
Last Updated
December 22, 2021
Sponsor
Medical University of Vienna
Collaborators
Berufsrettung Wien
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1. Study Identification

Unique Protocol Identification Number
NCT05185596
Brief Title
Prehospital TEE in Cardiac Arrest
Official Title
Feasibility of Prehospital Trans Esophageal Echocardiography in Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Berufsrettung Wien

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Out of hospital cardiac arrest (OOHCA) remains a leading cause of death in Austria. Current guidelines recommend to address potentially reversible causes for OOHCA early to improve survival and some of these causes can be recognized using echocardiography. The usefulness of trans-thoracic echocardiography during OOHCA seems to be limited as image acquisition may prolong now flow time and image quality is variable. These limitations might be overcome with trans-esophageal echocardiography. The investigators will investigate the feasibility of prehospital performed trans-esophageal echocardiography in ten OOHCA patients undergoing advanced life support. In addition to routine care by paramedics and emergency physicians, a dedicated expert in emergency ultrasound will perform trans-esophageal echocardiography in these patients. Primary outcome parameter: Is it possible to obtain trans-esophageal images of the heart within 10 minutes after arrival of the study team?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Echocardiography, Transesophageal, Out-of-Hospital Cardiac Arrest

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trans-esophageal echocardiography
Arm Type
Experimental
Arm Description
Transesophageal Echocardiography during advanced life support for out of hospital cardiac arrest will be performed.
Intervention Type
Device
Intervention Name(s)
Transesophageal Echocardiography
Intervention Description
transesophageal Echocardiography during advanced life support
Primary Outcome Measure Information:
Title
Time to obtain images of the heart
Description
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"
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Hands off times
Description
what are the "hands off times" (defined as time during which no chest compressions are performed during the resuscitation) during ALS with or without TEE.
Time Frame
10 minutes
Title
Hindering of advanced life support measures
Description
The number of events that hinder the established advanced life support measures will be counted graded by severity (minimal, minor, major)
Time Frame
10 minutes
Title
Trans esophageal echocardiography related complications
Description
What complications are caused by trans esophageal echocardiography occur during ALS: displacement of the endotracheal tube, dental injury, pharyngeal injury
Time Frame
10 minutes
Title
Image quality
Description
How is image quality of trans esophageal echocardiography during advanced life support measures? This will be determined by the investigator performing the trans esophageal echocardiography and also by a blinded specialist afterwards. The rating will be "excellent", "good", "moderate", "poor", "extremely poor"
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients undergoing advanced life support for out of hospital cardiac arrest Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Hamp, M.D.
Phone
+43140400
Ext
41030
Email
thomas.hamp@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hamp, M.D.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Hamp, M.D.
Phone
+4340400
Ext
41030
Email
thomas.hamp@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Prehospital TEE in Cardiac Arrest

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