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Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01148732
First received: June 8, 2010
Last updated: June 21, 2010
Last verified: June 2010

June 8, 2010
June 21, 2010
February 2010
February 2011   (final data collection date for primary outcome measure)
The endotracheal tube position [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
We use ultrasound to confirm the endotracheal tube position in emergency intubation
Same as current
Complete list of historical versions of study NCT01148732 on ClinicalTrials.gov Archive Site
Time required for each assessment [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
Time required for ultrasonoraphy, capnography and chest X-ray
Same as current
Not Provided
Not Provided
 
Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation
Tracheal Rapid Ultrasound Exam (T.R.U.E) for Confirming Endotracheal Tube Placement in Emergency Intubation

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patient needed emergency intubation in emergency department

Intubation
Procedure: ultrasonography
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.
Patient needed intubation in emergency department
Intervention: Procedure: ultrasonography
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients required intubation

Exclusion Criteria:

  • Head and Neck trauma
  • Head and Neck tumor
  • Status post tracheostomy
  • Status post neck surgery
  • Children (<18 years old)
Both
18 Years and older
No
Contact: Hao-Chang Chou, M.D 886972653256 erichaochang@gmail.com
Taiwan
 
NCT01148732
201003027R
No
Wan-Ching Lien/M.D., National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Wan-Ching Lien, M.D National Taiwan University Hospital
National Taiwan University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP