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The effectiveness of a miniature transoesophageal echocardiography (TOE) device to assess shock in trauma patients requiring rescuscitation

Transoesophageal echocardiography (TOE) in the early assessment of shocked trauma: A pilot study of a novel disposable miniaturised TOE device in the first hour of resuscitation.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001187538
Enrollment
10
Registered
2024-09-30
Start date
2024-10-01
Completion date
2025-12-31
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to find out if transesophageal echocardiography (TOE) is useful for assessing shock in patients with serious injuries, and helping with treatment and resuscitation of shocked patients. The images of the heart taken by the TOE device may help doctors in diagnosing and treating shock, and therefore in resuscitation efforts.

Interventions

The ClariTEE® Hemydynamic Ultrasound probe is a transoesophageal echocardiography (TOE) device. The TOE device is a miniature ultrasound camera on the end of a thin, flexible tube. It is inserted via the mouth and positioned in oesophagus behind the heart from where high definition close up ultrasound images of the heart can be obtained. The TOE is similar in size to routinely used nasogastric tubes. This device is expected to be inserted once within 60min of presentation to ED and will remain i

The ClariTEE® Hemydynamic Ultrasound probe is a transoesophageal echocardiography (TOE) device. The TOE device is a miniature ultrasound camera on the end of a thin, flexible tube. It is inserted via the mouth and positioned in oesophagus behind the heart from where high definition close up ultrasound images of the heart can be obtained. The TOE is similar in size to routinely used nasogastric tubes. This device is expected to be inserted once within 60min of presentation to ED and will remain in position for up to 20 minutes to allow adequate visualisation of the heart. The TOE will be used to assess shock in patients with major trauma who require resuscitation. It will only be used by doctors in the emergency department who have been trained in how to properly use it. The findings recorded by the clinician will be checked against the CT scan and / or operative findings to assess accuracy and sensitivity of this investigation.

Sponsors

Associate Professor Christopher Groombridge
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Intubated major trauma patients presenting during the study period Age 18 years and over Presenting directly from scene of injury Meeting ‘shocked trauma’ callout criteria: - Systolic blood pressure (SBP) less than 90mmHg at any time - Shock index > 1 (Heart Rate/SBP) - Prehospital blood transfusion

Exclusion criteria

- Not requiring intubation either prehospital or within 1 hour of arrival to the ED - Deceased on arrival - An Advanced Care Directive that precludes resuscitation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026