Prehospital TEE in Cardiac Arrest

Feasibility of Prehospital Trans Esophageal Echocardiography in Cardiac Arrest

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.

Study Overview

• Status: Recruiting
• Conditions: Out-of-Hospital Cardiac Arrest; Echocardiography, Transesophageal
• Intervention / Treatment: Device: Transesophageal Echocardiography

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?

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Hamp, M.D.; Phone Number: 41030 +43140400; Email: thomas.hamp@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Thomas Hamp, M.D.; Phone Number: 41030 +4340400; Email: thomas.hamp@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans-esophageal echocardiography; Transesophageal Echocardiography during advanced life support for out of hospital cardiac arrest will be performed.	Device: Transesophageal Echocardiography; transesophageal Echocardiography during advanced life support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes
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)	10 minutes
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	10 minutes
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"	10 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Berufsrettung Wien
• Investigators: Principal Investigator: Thomas Hamp, M.D., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 17182019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No