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

NCT03314519 | Completed Results FDA Device

• 1 other identifier: Skanavitoon
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Diseases; Ultrasonography; Fiberoptic Bronchoscopy; One Lung Ventilation; Thoracic Surgery; Lung Collapse

Keywords

Lung ultrasonography; Lung collapse; fiberoptic bronchoscopy; double lumen tube; compare; one lung ventilation; thoracic surgery; thoracic anaesthesia; lung ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Timing to Detect Lung Collapse

  30 minutes

• Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow

  30 minutes

Study Arms (2)

Ultrasonography

EXPERIMENTAL

Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.

Diagnostic Test: Lung ultrasonography by experienced anaesthesiologist

Fiberoptic bronchoscopy

ACTIVE COMPARATOR

Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.

Diagnostic Test: Fiberoptic bronchoscopy for double lumen tube's position

Interventions

Lung ultrasonography by experienced anaesthesiologist DIAGNOSTIC_TEST

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

Ultrasonography

Fiberoptic bronchoscopy for double lumen tube's position DIAGNOSTIC_TEST

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

Fiberoptic bronchoscopy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (18)

• Bussieres JS, Somma J, Del Castillo JL, Lemieux J, Conti M, Ugalde PA, Gagne 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.

  PMID: 27138896 BACKGROUND

• 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. doi: 10.1016/s0952-8180(98)00081-6.

  PMID: 9805696 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

• Cohen E. Double-lumen tube position should be confirmed by fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2004 Feb;17(1):1-6. doi: 10.1097/00001503-200402000-00002.

  PMID: 17021522 BACKGROUND

• 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.

  PMID: 26379290 BACKGROUND

• 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. No abstract available.

  PMID: 27053795 BACKGROUND

• 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.

  PMID: 18456211 BACKGROUND

• 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.

  PMID: 23513327 BACKGROUND

• Acosta CM, Maidana GA, Jacovitti D, Belaunzaran 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.

  PMID: 24662376 BACKGROUND

• 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.

  PMID: 31333372 BACKGROUND

• 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.

  PMID: 26257857 BACKGROUND

• 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.

  PMID: 24432174 BACKGROUND

• 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.

  PMID: 26474994 BACKGROUND

• 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.

  PMID: 21802958 BACKGROUND

• 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.

  PMID: 25711517 BACKGROUND

• 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

• 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.

  PMID: 30205667 BACKGROUND

• Kanavitoon S, Raksamani K, Troy MP, Suphathamwit A, Thongcharoen P, Suksompong S, Oh SS. Lung ultrasound is non-inferior to bronchoscopy for confirmation of double-lumen endotracheal tube positioning: a randomized controlled noninferiority study. BMC Anesthesiol. 2022 May 30;22(1):168. doi: 10.1186/s12871-022-01707-4.

  PMID: 35637457 DERIVED

MeSH Terms

Conditions

Lung Diseases; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Limitations and Caveats

Ultrasonographer needs to be completely blind due to clinical visualization of chest rising after intubation before and during perform ultrasonography.

Results Point of Contact

• Title: Kasana Raksamanee
• Organization: Mahidol University

kasana@gmail.com

66967841010

Study Officials

• Kasana Raksamani, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 19, 2017
• Study Start: October 20, 2017
• Primary Completion: July 10, 2019
• Study Completion: July 31, 2019
• Last Updated: March 12, 2020
• Results First Posted: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)