NCT06249035

Brief Summary

The goal of this feasibility study is to learn if Dutch ED providers are able to use transesophageal echocardiography during cardiac arrest. The main question it aims to answer is: • are the ED providers able to determine the area of maximal compression of the heart using TEE

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

January 31, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

transoesophageal echocardiographyPOCUSEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Area of maximal compression (AMC)

    The percentage of patients in which providers are able to determine the location of the AMC during cardiac arrest.

    First 30 minutes of cardiac arrest treatment in the ED.

Secondary Outcomes (5)

  • Location of AMC

    First 30 minutes of cardiac arrest treatment in the ED.

  • Accuracy of AMC

    First 30 minutes of cardiac arrest treatment in the ED.

  • Safety of TEE

    First 30 minutes of cardiac arrest treatment in the ED.

  • Intubation

    First 30 minutes of cardiac arrest treatment in the ED.

  • Time to image

    First 30 minutes of cardiac arrest treatment in the ED.

Study Arms (1)

TEE as POCUS modality.

EXPERIMENTAL

TEE will be performed during cardiac arrest.

Diagnostic Test: Transoesophageal echocardiography (TEE)

Interventions

TEE is a diagnostic modality in which an ultrasound probe is inserted via the oesophagus in order to visualize the heart.

TEE as POCUS modality.

Eligibility Criteria

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

You may qualify if:

  • Patients with cardiac arrest \> 18 year in the emergency department.

You may not qualify if:

  • Patients with known upper gastro-intestinal malignancy or strictures, previous upper gastro-intestinal surgery or radiation, or known esophageal varices.
  • Patient with a do-not-resuscitate order, pregnant patients and traumatic cardiac arrest.
  • No trained TEE provider available.
  • ROSC at arrival.
  • Decision by the team to stop resuscitation at arrival at the emergency department due of prognosis.
  • Other life saving interventions which are prioritized over TEE by the resuscitation team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart ArrestEmergencies

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Peter Veldhuis, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: TEE will be performed on all patients that are eligible for inclusion.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

June 25, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations