- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06178471
Safety, Feasibility and Clinical Utility of Critical Care Transesophageal Echocardiography in Hong Kong (SAFE-TEE)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wincy Ng, MRCP
- Phone Number: 64806646
- Email: wincyngwingsze@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 20231212-006-000
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
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.
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