Cardiopulmonary FailureSAFE-TEENCT06178471
Safety, Feasibility and Clinical Utility of Critical Care Transesophageal Echocardiography in Hong Kong
An observational study of Cardiopulmonary Failure, run by Queen Mary Hospital, Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiopulmonary Failure
- What is being tested?
- Transesophageal Echocardiography
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2025to 1 Jul 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who suffer from cardiopulmonary failure requiring intubation and invasive mechanical ventilation, who benefit from detailed hemodynamic assessment by transesophageal echocardiography.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
- Conditions
- Cardiopulmonary Failure
- Being tested
- Transesophageal Echocardiography
- Keywords
- Echocardiography, Transesophageal Echocardiography, Critical Care Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyDiagnostic test
The use of transesophageal echocardiography to diagnose cardiopulmonary failure in ICU patients with suboptimal or inadequate transthoracic echocardiography examinations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication of TEE use in the ICU
TEE complications include esophageal perforation, upper gastrointestinal bleeding, loss of artificial airway, oral bleeding, dental injury, odynophagia, mortality
Measured: Within 1 week following the TEE examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start8 Sep 2025
- Primary completion1 Jan 2026
- Study completion1 Jul 2026
Why it stopped: study design amended to retrospective analysis due to institutional constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178471
- Sponsor's protocol ID
- 20231212-006-000
- Acronym
- SAFE-TEE
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility and Clinical Utility of Critical Care Transesophageal Echocardiography in Hong Kong
- ClinicalTrials.gov ID
- NCT06178471
- Acronym / sponsor ID
- SAFE-TEE / 20231212-006-000
- Conditions
- Cardiopulmonary Failure
- Keywords
- Echocardiography, Transesophageal Echocardiography, Critical Care Echocardiography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study design amended to retrospective analysis due to institutional constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who suffer from cardiopulmonary failure requiring intubation and invasive mechanical ventilation, who benefit from detailed hemodynamic assessment by transesophageal echocardiography.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- Patient possessing absolute contraindication(s) to TEE examination according to the ASE guideline 2013:
- Perforated viscus
- Esophageal stricture
- Esophageal tumor
- Esophageal perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal EchocardiographyThe use of transesophageal echocardiography to diagnose cardiopulmonary failure in ICU patients with suboptimal or inadequate transthoracic echocardiography examinations. | Diagnostic test | – |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Failure, run by Queen Mary Hospital, Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication of TEE use in the ICU (time frame: Within 1 week following the TEE examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.