Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06249035
Other study ID # EDTEE2024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date May 1, 2025

Study information

Verified date January 2024
Source Medical Centre Leeuwarden
Contact Peter Veldhuis, MD
Phone +3158 286 6666
Email peter.veldhuis@mcl.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Point-of-care ultrasound is a valuable diagnostic tool during cardiopulmonary resuscitation (CPR) in cardiac arrest and its use is recommended by international guidelines. Transthoracic echocardiography (TTE) is most commonly used, but has certain limitations. Image acquisition can be challenging due to patient specific factors such as body habitus. Also image quality may be impacted by the limited acquisition time during CPR pulse checks. Furthermore, observational data suggests that pulse checks are prolonged due to TTE, while minimizing interruption of chest compressions is emphasized for better CPR outcomes in the guidelines. Transesophageal ultrasound (TEE) is a possible alternative for TTE. It has the theoretical advantage of superior image quality and thereby possible reductions of chest compression delays. Furthermore, TEE gives the opportunity determine which part of the heart is compressed most effectively, which is referred to as the area of maximal compression (AMC). Animal studies showed that an AMC located over the left ventricle positively influenced hemodynamics and return of spontaneous circulation (ROSC) compared to an AMC over the aortic root. In human studies, data also suggests that AMC located on the left ventricle, as measured by TEE, may positively influence prognosis. In the Netherlands, TEE is currently not used in emergency departments during cardiac arrest. The purpose of this study is to investigate if point-of-care TEE can be used effectively and safely by providers and teams that have not previously used this modality. Given the paramount importance of quality of chest compressions, the ability of the providers to assess the location of the AMC will be the main focus of this feasibility study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with cardiac arrest > 18 year in the emergency department. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Transoesophageal echocardiography (TEE)
TEE is a diagnostic modality in which an ultrasound probe is inserted via the oesophagus in order to visualize the heart.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Medical Centre Leeuwarden Onze Lieve Vrouwe Gasthuis

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Location of AMC The echographic location of the AMC, subcategorised as: left ventricle, left ventricular outflow tract/aortic root, other, not able to determine AMC First 30 minutes of cardiac arrest treatment in the ED.
Secondary Accuracy of AMC Accuracy of AMC defined as correlation between providers interpretation of AMC and reviewers interpretation of AMC First 30 minutes of cardiac arrest treatment in the ED.
Secondary Safety of TEE Incidence of complications of TEE First 30 minutes of cardiac arrest treatment in the ED.
Secondary Intubation Need for intubation for using TEE and duration of intubation First 30 minutes of cardiac arrest treatment in the ED.
Secondary Time to image Time from start ED treatment to first TEE image First 30 minutes of cardiac arrest treatment in the ED.
See also
  Status Clinical Trial Phase
Recruiting NCT06048068 - Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events N/A
Recruiting NCT05558228 - Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Completed NCT03685383 - Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Completed NCT04619498 - Effectiveness of an Interactive Cognitive Support Tablet App to Improve the Management of Pediatric Cardiac Arrest N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT02352350 - Lactate in Cardiac Arrest N/A
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT02247947 - Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Completed NCT02275234 - Care After Resuscitation
Completed NCT01972087 - Simulation Training to Improve 911 Dispatcher Identification of Cardiac Arrest N/A
Completed NCT01944605 - Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest N/A
Completed NCT01936597 - Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage N/A
Active, not recruiting NCT01239420 - Norwegian Cardio-Respiratory Arrest Study
Completed NCT01191736 - Ultra-Brief Versus Brief Hands Only CPR Video Training With and Without Psychomotor Skill Practice N/A
Completed NCT00878644 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial Phase 3
Completed NCT00880087 - Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial N/A
Completed NCT00729794 - Vasopressin, Epinephrine, and Steroids for Cardiac Arrest Phase 3
Recruiting NCT00441753 - Cerebral Bloodflow and Carbondioxide Reactivity During Mild Therapeutic Hypothermia in Patients After Cardiac Arrest N/A
Completed NCT00347477 - Fluid Shifts in Patients Treated With Therapeutic Hypothermia After Cardiac Arrest Phase 3