Lung Ultrasonography vs Fiberoptic Bronchoscopy for Aiding Lung Collapse in Patient Using Double Lumen Tube

Lung Diseases Clinical Trial

Official title:

A Randomized Controlled Study Compare Lung Ultrasonography to Fiberoptic Bronchoscopy Confirming Double Lumen Tube Positioning for Thoracic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314519
• Other study ID #: Skanavitoon
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as the standard test.

Description:

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as a standard test. Both of them detect lung collapse reported as surgical grading lung collapse by the thoracic surgeons. The protocol was performed in a randomized controlled trial whether the subject was allocated to the ultrasonography group or the fiberoptic bronchoscopy group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, age =18 years old

• American Society of Anesthesiologists(ASA) physical status classification I - III

• Scheduled for elective thoracic surgery which requires One lung ventilation(OLV) with Left-sided double lumen tube

Exclusion Criteria:

• Anticipated difficult intubation or with the tracheostomy tube

• Patient with pneumothorax, pleural effusion, emphysema or past history of pleurodesis

• Patient with deranges pulmonary function test (out of forced expiration volume in 1 s, total lung capacity, forced vital capacity <50% of the predicted values)

• The patient refuses to participate.

Related Conditions & MeSH terms

• Fiberoptic Bronchoscopy
• Lung Collapse
• Lung Diseases
• One Lung Ventilation
• Pulmonary Atelectasis
• Shock
• Thoracic Surgery
• Ultrasonography

Intervention

Diagnostic Test:
• Lung ultrasonography by experienced anaesthesiologist
Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard
• Fiberoptic bronchoscopy for double lumen tube's position
Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (17)

Acosta CM, Maidana GA, Jacovitti D, Belaunzarán A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231. — View Citation

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

Boucek CD, Landreneau R, Freeman JA, Strollo D, Bircher NG. A comparison of techniques for placement of double-lumen endobronchial tubes. J Clin Anesth. 1998 Nov;10(7):557-60. — View Citation

Bussières JS, Somma J, Del Castillo JL, Lemieux J, Conti M, Ugalde PA, Gagné N, Lacasse Y. Bronchial blocker versus left double-lumen endotracheal tube in video-assisted thoracoscopic surgery: a randomized-controlled trial examining time and quality of lung deflation. Can J Anaesth. 2016 Jul;63(7):818-27. doi: 10.1007/s12630-016-0657-3. Epub 2016 May 2. — View Citation

Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21. Review. — View Citation

Cohen E. Double-lumen tube position should be confirmed by fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2004 Feb;17(1):1-6. — View Citation

de Bellis M, Accardo R, Di Maio M, La Manna C, Rossi GB, Pace MC, Romano V, Rocco G. Is flexible bronchoscopy necessary to confirm the position of double-lumen tubes before thoracic surgery? Eur J Cardiothorac Surg. 2011 Oct;40(4):912-6. doi: 10.1016/j.ejcts.2011.01.070. Epub 2011 Jul 29. Erratum in: Eur J Cardiothorac Surg. 2012 Jun;41(6):1411. Lamanna, Carmine [corrected to La Manna, Carmine]. — View Citation

Diaz NG. "A prospective comparative study to evaluate the utility of lung ultrasonography to improve the accuracy of traditional clinical methods to confirm position of left sided double lumen tube in elective thoracic surgeries". Indian J Anaesth. 2016 Mar;60(3):226-7. doi: 10.4103/0019-5049.177880. — View Citation

Kitabjian L, Bordi S, Elisha S, Gabot M, Heiner J, Nagelhout J, Thompson J. Anesthesia case management for video-assisted thoracoscopic surgery. AANA J. 2013 Feb;81(1):65-72. — View Citation

Lohser J. Evidence-based management of one-lung ventilation. Anesthesiol Clin. 2008 Jun;26(2):241-72, v. doi: 10.1016/j.anclin.2008.01.011. Review. — View Citation

Nam JS, Park I, Seo H, Min HG. The use of lung ultrasonography to confirm lung isolation in an infant who underwent emergent video-assisted thoracoscopic surgery: a case report. Korean J Anesthesiol. 2015 Aug;68(4):411-4. doi: 10.4097/kjae.2015.68.4.411. Epub 2015 Jul 28. — View Citation

Parab SY, Divatia JV, Chogle A. A prospective comparative study to evaluate the utility of lung ultrasonography to improve the accuracy of traditional clinical methods to confirm position of left sided double lumen tube in elective thoracic surgeries. Indian J Anaesth. 2015 Aug;59(8):476-81. doi: 10.4103/0019-5049.162983. — View Citation

Parab SY, Kumar P, Divatia JV, Sharma K. A prospective randomized controlled double-blind study comparing auscultation and lung ultrasonography in the assessment of double lumen tube position in elective thoracic surgeries involving one lung ventilation at a tertiary care cancer institute. Korean J Anesthesiol. 2019 Feb;72(1):24-31. doi: 10.4097/kja.d.17.00081. Epub 2018 Sep 12. — View Citation

Saporito A, Lo Piccolo A, Franceschini D, Tomasetti R, Anselmi L. Thoracic ultrasound confirmation of correct lung exclusion before one-lung ventilation during thoracic surgery. J Ultrasound. 2013 Nov 9;16(4):195-9. doi: 10.1007/s40477-013-0050-9. eCollection 2013 Nov 9. — View Citation

See KC, Ong V, Wong SH, Leanda R, Santos J, Taculod J, Phua J, Teoh CM. Lung ultrasound training: curriculum implementation and learning trajectory among respiratory therapists. Intensive Care Med. 2016 Jan;42(1):63-71. doi: 10.1007/s00134-015-4102-9. Epub 2015 Oct 16. — 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

Yamaguchi Y, Moharir A, Burrier C, Tobias JD. Point-of-care lung ultrasound to evaluate lung isolation during one-lung ventilation in children: A case report. Saudi J Anaesth. 2019 Jul-Sep;13(3):243-245. doi: 10.4103/sja.SJA_115_19. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy	Compare number of patients with lung collapse detected by ultrasonography and fiberoptic bronchoscopy in patient with double lumen tube by report as specificity and sensitivity of detection of lung collapse by compare to visual grading of lung collapse by surgeon	30 minutes
Secondary	Timing to Detect Lung Collapse	Time point from evaluation of lung collapse by each test to time point of grading lung collapse by gold standard( visual grading of lung collapse by surgeon)	30 minutes
Secondary	Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow	Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography	30 minutes