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

NCT ID: NCT03314519

Last Updated: 2020-03-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Ultrasonography

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.

Group Type EXPERIMENTAL

Lung ultrasonography by experienced anaesthesiologist

Intervention Type 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

Fiberoptic bronchoscopy

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.

Group Type ACTIVE_COMPARATOR

Fiberoptic bronchoscopy for double lumen tube's position

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kasana Raksamani, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 27138896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9805696 (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)

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.

Reference Type BACKGROUND
PMID: 17021522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26379290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27053795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18456211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23513327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24662376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31333372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26257857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24432174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26474994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21802958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25711517 (View on PubMed)

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)

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.

Reference Type BACKGROUND
PMID: 30205667 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35637457 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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Skanavitoon

Identifier Type: -

Identifier Source: org_study_id

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