Ultrasound for Double Lumen Endotracheal Tube

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

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

Study Overview

• Status: Terminated
• Conditions: Lung Ultrasound
• Intervention / Treatment: Device: Determination of tube position by ultrasound.; Other: Determination of tube position by auscultation.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 56429
    • Anesthesia department; 424 Army General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; Determination of correct placement of the double lumen tube by lung ultrasound.	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.
Active Comparator: Clinical; Determination of correct placement of the double lumen tube by clinical examination.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: 424 General Military Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Alvarez-Diaz N, Amador-Garcia I, Fuentes-Hernandez 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 20, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Double lumen tube
• Other Study ID Numbers: 14074