- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185596
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
Intervention / Treatment
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
Enrollment (Anticipated)
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
-
-
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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
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
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 Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
What complications are caused by trans esophageal echocardiography occur during ALS: displacement of the endotracheal tube, dental injury, pharyngeal injury
|
10 minutes
|
|
Image quality
Time Frame: 10 minutes
|
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
Collaborators
Investigators
- Principal Investigator: Thomas Hamp, M.D., Medical University of Vienna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17182019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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