Ultrasound for Double Lumen Endotracheal Tube

Lung Ultrasound Clinical Trial

Official title:

Comparison Between Ultrasound and Clinical Assessment of the Correct Positioning of Left Double Lumen Endotracheal Tube

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02556853
• Other study ID #: 14074
• Status: Terminated
• Phase: N/A
• First received: September 20, 2015
• Last updated: January 8, 2018
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®). The two methods will be compared in terms of sensitivity and specificity. The main purpose of the study is to determine if the ultrasound can be used for determination of the correct placement of the left sided double lumen endotracheal tube

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Surgery requiring placement of double-lumen endotracheal tube.

• ASA 1-3

Exclusion Criteria:

• History of difficult or impossible intubation.

• Clinical findings of possible difficult intubation according to the standard preoperative airway assessment.

• Impossible placement of a double lumen tube

Related Conditions & MeSH terms

• Lung Ultrasound

Intervention

Device:
• Determination of tube position by ultrasound.
After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by ultrasound (Sonoscape S6®). The ultrasound probe will be placed between the 2nd and 3rd intercostal space at the level of the midclavicular line parallel to the line. The probe will be slightly moved or tilted until the pleural line is identified. If lung sliding is identified then the ventilation of the lung will be considered adequate. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.

Other:
• Determination of tube position by auscultation.
After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by auscultation of the upper lung fields. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.

Locations

Country	Name	City	State
Greece	Anesthesia department; 424 Army General Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Álvarez-Díaz N, Amador-García I, Fuentes-Hernández M, Dorta-Guerra R. Comparison between transthoracic lung ultrasound and a clinical method in confirming the position of double-lumen tube in thoracic anaesthesia. A pilot study. Rev Esp Anestesiol Reanim. 2015 Jun-Jul;62(6):305-12. doi: 10.1016/j.redar.2014.06.005. Epub 2014 Aug 20. English, Spanish. — View Citation

Sustic A, Miletic D, Protic A, Ivancic A, Cicvaric T. Can ultrasound be useful for predicting the size of a left double-lumen bronchial tube? Tracheal width as measured by ultrasonography versus computed tomography. J Clin Anesth. 2008 Jun;20(4):247-52. doi: 10.1016/j.jclinane.2007.11.002. — View Citation

Sustic A, Protic A, Cicvaric T, Zupan Z. The addition of a brief ultrasound examination to clinical assessment increases the ability to confirm placement of double-lumen endotracheal tubes. J Clin Anesth. 2010 Jun;22(4):246-9. doi: 10.1016/j.jclinane.2009.07.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct position of the tube (yes/no).	The anesthesiologist who will place the left-sided double lumen tube will determine if the position of the tube is correct according to the ultrasound or clinical findings.	Within an average of 5 minutes after the placement of the double lumen tube
Primary	Correct position of the tube by bronchoscopy (yes/no).	After the assessment of the tube's position, a second anesthesiologist will verify the position of the tube by bronchoscopy.	Within an average of 10 minutes after the placement of the double lumen tube.
Secondary	Time needed	The total time passed from the beginning of laryngoscopy until the final verification of the tube's position.	Within an average of 10 minutes after the placement of the double lumen tube.