Ultrasound for Double Lumen Endotracheal Tube

NCT02556853 | Terminated

• 1 other identifier: 14074
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Ultrasound

Keywords

Ultrasound; Double lumen tube

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Time needed

  Within an average of 10 minutes after the placement of the double lumen tube.

Study Arms (2)

Ultrasound

EXPERIMENTAL

Determination of correct placement of the double lumen tube by lung ultrasound.

Device: Determination of tube position by ultrasound.

Clinical

ACTIVE COMPARATOR

Determination of correct placement of the double lumen tube by clinical examination.

Other: Determination of tube position by auscultation.

Interventions

Determination of tube position by ultrasound. DEVICE

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.

Ultrasound

Determination of tube position by auscultation. OTHER

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.

Clinical

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgery requiring placement of double-lumen endotracheal tube.
• ASA 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• 424 General Military Hospital: lead

Study Sites (1)

Anesthesia department; 424 Army General Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (3)

• 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.

  PMID: 20522353 BACKGROUND

• 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.

  PMID: 18617120 BACKGROUND

• 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.

  PMID: 25149114 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 20, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

GR (1)