IntubationNCT01148732
Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation
An observational study of Intubation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill patients. Incorrect placement causes a high rate of mortality and morbidity. Therefore, early detection of accidental esophageal intubation must be a primary focus of emergency airway efforts in emergency department (ED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to Feb 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient needed emergency intubation in emergency department
Who may be able to join
- Patients required intubation
Who cannot join
- Head and Neck trauma
- Head and Neck tumor
- Status post tracheostomy
- Status post neck surgery
- Children (<18 years old)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill patients. Incorrect placement causes a high rate of mortality and morbidity. Therefore, early detection of accidental esophageal intubation must be a primary focus of emergency airway efforts in emergency department (ED). Although many techniques have been suggested to verify the ETT placement, there is currently no entirely reliable method. Ultrasonography (US) is an indispensable and easily accessible tool in ED. Several studies of ultrasonographic confirmation of ETT position provided promising results in cadaver model or patient in a controlled operating room setting.In this study, the investigators have proposed a protocol called T.R.U.E, an acronym for tracheal rapid ultrasound exam, to confirm the ETT position in emergency intubation. This method provided a fast, real-time examination to prevent esophageal or endotracheal intubation.
Read the detailed description
Establishing a definite airway, endotracheal tube placement, is an important component for resuscitation. A high rate of morbidity and mortality was reported for unrecognized esophageal intubation. Therefore, early detection of esophageal intubation is essential for emergency airway management. There are several methods being used for endotracheal tube confirmation, such as auscultation of breathing sound, chest X-ray and capnography.2 However, all of these methods had false-negative rates and not entirely reliable during resuscitation. Ultrasound is an indispensable and easily accessible tool in emergency department. Recent studies showed that ultrasound can be used to confirm endotracheal tube placement in cadaver model. In this prospective study, we investigate the sensitivity and specificity of ultrasound for endotracheal tube confirmation in emergency intubation The study is conducted in the emergency department at National Taiwan University Hospital and approved by the hospital institutional review board. During resuscitation, the duty emergency resuscitation team performs the intubation and confirms the endotracheal tube position by auscultation and end-tidal capnography. Meanwhile, the researcher performs ultrasonography examinations for endotracheal tube position. A curvilinear ultrasonography transducer is used and placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax. The result of ultrasonography will be compared with auscultation, capnography and chest X-ray. Sensitivity and specificity of ultrasonography examination is computed to determine the accuracy and effectiveness of clinical use.
- Conditions
- Intubation
- Being tested
- ultrasonography
- Keywords
- Endotracheal tube, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyProcedure or surgery
a Toshiba 3.75 MHz convex ultrasonography transducer (Toshiba SSA-550A, Tochigi-ken, Japan) was placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax by one of two emergency physician during emergency intubation investigators.
| Study group | Role | What they receive |
|---|---|---|
| Patient needed intubation in emergency department | Not described Receives: Procedure: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endotracheal tube position
We use ultrasound to confirm the endotracheal tube position in emergency intubation
Measured: 5 minutes
Secondary outcomes (1)
Time required for each assessment
Time required for ultrasonoraphy, capnography and chest X-ray
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wan-Ching Lien, M.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148732
- Sponsor's protocol ID
- 201003027R
- Status last verified
- Jun 2010
- First submitted
- 8 Jun 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chou HC, Tseng WP, Wang CH, Ma MH, Wang HP, Huang PC, Sim SS, Liao YC, Chen SY, Hsu CY, Yen ZS, Chang WT, Huang CH, Lien WC, Chen SC. Tracheal rapid ultrasound exam (T.R.U.E.) for confirming endotracheal tube placement during emergency intubation. Resuscitation. 2011 Oct;82(10):1279-84. doi: 10.1016/j.resuscitation.2011.05.016. Epub 2011 Jun 1.
PubMed 21684668
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation
- ClinicalTrials.gov ID
- NCT01148732
- Acronym / sponsor ID
- 201003027R
- Conditions
- Intubation
- Keywords
- Endotracheal tube, ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 22 Jun 2010 (estimated)
- 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.
Reliable endotracheal tube (ETT) insertion confirmation is essential for critically ill patients. Incorrect placement causes a high rate of mortality and morbidity. Therefore, early detection of accidental esophageal intubation must be a primary focus of emergency airway efforts in emergency department (ED). Although many techniques have been suggested to verify the ETT placement, there is currently no entirely reliable method. Ultrasonography (US) is an indispensable and easily accessible tool in ED. Several studies of ultrasonographic confirmation of ETT position provided promising results in cadaver model or patient in a controlled operating room setting.In this study, the investigators have proposed a protocol called T.R.U.E, an acronym for tracheal rapid ultrasound exam, to confirm the ETT position in emergency intubation. This method provided a fast, real-time examination to prevent esophageal or endotracheal intubation.
Detailed description
Establishing a definite airway, endotracheal tube placement, is an important component for resuscitation. A high rate of morbidity and mortality was reported for unrecognized esophageal intubation. Therefore, early detection of esophageal intubation is essential for emergency airway management. There are several methods being used for endotracheal tube confirmation, such as auscultation of breathing sound, chest X-ray and capnography.2 However, all of these methods had false-negative rates and not entirely reliable during resuscitation. Ultrasound is an indispensable and easily accessible tool in emergency department. Recent studies showed that ultrasound can be used to confirm endotracheal tube placement in cadaver model. In this prospective study, we investigate the sensitivity and specificity of ultrasound for endotracheal tube confirmation in emergency intubation The study is conducted in the emergency department at National Taiwan University Hospital and approved by the hospital institutional review board. During resuscitation, the duty emergency resuscitation team performs the intubation and confirms the endotracheal tube position by auscultation and end-tidal capnography. Meanwhile, the researcher performs ultrasonography examinations for endotracheal tube position. A curvilinear ultrasonography transducer is used and placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax. The result of ultrasonography will be compared with auscultation, capnography and chest X-ray. Sensitivity and specificity of ultrasonography examination is computed to determine the accuracy and effectiveness of clinical use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient needed intubation in emergency department | – | Procedure: ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient needed emergency intubation in emergency department
Key inclusion criteria (1 listed)
- Patients required intubation
Key exclusion criteria (5 listed)
- Head and Neck trauma
- Head and Neck tumor
- Status post tracheostomy
- Status post neck surgery
- Children (<18 years old)
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 |
|---|---|---|
| ultrasonographya Toshiba 3.75 MHz convex ultrasonography transducer (Toshiba SSA-550A, Tochigi-ken, Japan) was placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax by one of two emergency physician during emergency intubation investigators. | Procedure or surgery | Patient needed intubation in emergency department |
Primary outcome
The endotracheal tube position
Time frame: 5 minutes
We use ultrasound to confirm the endotracheal tube position in emergency intubation
1 secondary outcome
Time required for each assessment
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 21684668Chou HC, Tseng WP, Wang CH, Ma MH, Wang HP, Huang PC, Sim SS, Liao YC, Chen SY, Hsu CY, Yen ZS, Chang WT, Huang CH, Lien WC, Chen SC. Tracheal rapid ultrasound exam (T.R.U.E.) for confirming endotracheal tube placement during emergency intubation. Resuscitation. 2011 Oct;82(10):1279-84. doi: 10.1016/j.resuscitation.2011.05.016. Epub 2011 Jun 1.
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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.
Wan-Ching Lien, M.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao-Chang Chou, M.D (886972653256, erichaochang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endotracheal tube position (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148732, which also lists 1 linked publication.
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 22 Jun 2010.