Ultrasound for Double Lumen Endotracheal Tube

NCT ID: NCT02556853

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Lung Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound

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

Group Type EXPERIMENTAL

Determination of tube position by ultrasound.

Intervention Type 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.

Clinical

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

Group Type ACTIVE_COMPARATOR

Determination of tube position by auscultation.

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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424 General Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Georgios Kotsovolis

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anesthesia department; 424 Army General Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 20522353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18617120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25149114 (View on PubMed)

Other Identifiers

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14074

Identifier Type: -

Identifier Source: org_study_id

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