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

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01148732
• Other study ID #: 201003027R
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2010
• Last updated: June 21, 2010
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: Hao-Chang Chou, M.D
• Phone: 886972653256
• Email: erichaochang[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intubation

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The endotracheal tube position	We use ultrasound to confirm the endotracheal tube position in emergency intubation	5 minutes	Yes
Secondary	Time required for each assessment	Time required for ultrasonoraphy, capnography and chest X-ray	1 hour	Yes