Safety, Feasibility and Clinical Utility of Critical Care Transesophageal Echocardiography in Hong Kong (SAFE-TEE)

April 1, 2024 updated by: Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong

Critical care echocardiography is increasingly recognized as an essential skill for intensivists to achieve during their training and fellowship. It serves to provide critical information to guide clinical management in patients with hemodynamic collapse and respiratory insufficiency. While transthoracic echocardiography (TTE) could be adequate for assessment in most situations, patient factors such as body habitus, presence of chest drains and tubes, presence of thoracic surgical dressings, requirement of high ventilatory support may impede operators from obtaining satisfactory images for evaluation. Moreover, operators in TTE require time and experience for adequate skill and technique acquisition. In specific pathologies such as infective endocarditis, presence of thrombus in left atrial appendage, and evaluation of intracardiac shunts, TEE has been shown to be superior to TTE for proper and accurate diagnosis. Therefore, TEE is widely accepted as the preferred and essential modality for echocardiographic examination especially in European countries. Countries such as France and North American have included critical care TEE as a core curriculum in the critical care training pathway.

In Hong Kong, only basic critical care echocardiography using TTE is required during training and in clinical practice. TEE evaluation is mostly performed in cardiac surgery units by cardiac anesthetists and in stable patients by cardiologists. Critical care TEE is seldom performed by intensivists independently for hemodynamic assessment and evaluation of cardiopulmonary failure. This study describes the safety, feasibility, and clinical utility of critical care TEE by critical care fellows in a university-affiliated institute providing tertiary care to the territory. With implementation of this essential technique in a single center, this study serves to act as a generalizable guidance to achieve an ultimate goal of incorporating this technique as core curriculum in critical care training in parts of the world where critical care TEE is not well established.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who suffer from cardiopulmonary failure requiring intubation and invasive mechanical ventilation, who benefit from detailed hemodynamic assessment by transesophageal echocardiography.

Description

Inclusion Criteria:

  • Age ≧ 18; AND
  • Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
  • Intubated for invasive mechanical ventilation; AND
  • Clinically indicated for transesophageal echocardiography (TEE)

Exclusion Criteria:

Patient possessing absolute contraindication(s) to TEE examination according to the ASE guideline 2013:

  • Perforated viscus
  • Esophageal stricture
  • Esophageal tumor
  • Esophageal perforation
  • Esophageal laceration
  • Esophageal diverticulum
  • Active upper gastrointestinal bleed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication of TEE use in the ICU
Time Frame: Within 1 week following the TEE examination
TEE complications include esophageal perforation, upper gastrointestinal bleeding, loss of artificial airway, oral bleeding, dental injury, odynophagia, mortality
Within 1 week following the TEE examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 8, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 20231212-006-000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiopulmonary Failure

Clinical Trials on Transesophageal Echocardiography

3
Subscribe