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

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03314519
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.3
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases; Ultrasonography; Fiberoptic Bronchoscopy; One Lung Ventilation; Thoracic Surgery; Lung Collapse	Diagnostic Test: Lung ultrasonography by experienced anaesthesiologist; Diagnostic Test: Fiberoptic bronchoscopy for double lumen tube's position	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Randomized Controlled Study Compare Lung Ultrasonography to Fiberoptic Bronchoscopy Confirming Double Lumen Tube Positioning for Thoracic Surgery.
• Actual Study Start Date: Oct 20, 2017
• Actual Primary Completion Date: Jul 10, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
Active Comparator: 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.	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

Outcome Measures

Primary Outcome Measures

1. Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy [30 minutes]

   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

Secondary Outcome Measures

1. Timing to Detect Lung Collapse [30 minutes]

   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)

2. Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow [30 minutes]

   Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahidol University	Bangkok Noi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Kasana Raksamani, MD, Siriraj Hospital

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 23, 2020
• Study Protocol - Mar 10, 2020

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Cohen E. Double-lumen tube position should be confirmed by fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2004 Feb;17(1):1-6.
• 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].
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Sustić A, Protić A, Cicvarić 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.
• 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.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03314519
• Other Study ID Numbers: Skanavitoon
• First Posted: Oct 19, 2017
• Last Update Posted: Mar 12, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Mahidol University: Lung ultrasonography; Lung collapse; fiberoptic bronchoscopy; double lumen tube; compare; one lung ventilation; thoracic surgery; thoracic anaesthesia; lung ultrasound
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Atelectasis; Shock

Study Results

Participant Flow

Arm/Group Title	Ultrasonography	Fiberoptic Bronchoscopy
Arm/Group Description	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. 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	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. 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
Period Title: Overall Study
STARTED	100	100
COMPLETED	97	98
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Ultrasonography	Fiberoptic Bronchoscopy	Total
Arm/Group Description	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. 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	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. 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	Total of all reporting groups
Overall Participants	97	98	195
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.4 (15.6)	60.6 (12.8)	60.5 (14.3)
Sex: Female, Male (Count of Participants)
Female	59 60.8%	50 51%	109 55.9%
Male	38 39.2%	48 49%	86 44.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Thailand	97 100%	98 100%	195 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	24.4 (4.4)	24.0 (4.3)	24.2 (4.3)

Outcome Measures

1. Primary Outcome

Title	Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy
Description	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
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasonography	Fiberoptic Bronchoscopy
Arm/Group Description	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. 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	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. 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
Measure Participants	97	98
Count of Participants [Participants]	89 91.8%	83 84.7%

2. Secondary Outcome

Title	Timing to Detect Lung Collapse
Description	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)
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasonography	Fiberoptic Bronchoscopy
Arm/Group Description	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. 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	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. 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
Measure Participants	97	98
Median (Full Range) [minutes]	14	9

3. Secondary Outcome

Title	Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow
Description	Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ultrasonography	Fiberoptic Bronchoscopy
Arm/Group Description	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. 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	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. 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
Measure Participants	97	98
Count of Participants [Participants]	89 91.8%	83 84.7%

Adverse Events

Time Frame	Total intraoperative period, an average of 1 hour
Adverse Event Reporting Description	Desaturation
Arm/Group Title	Ultrasonography		Fiberoptic Bronchoscopy
Arm/Group Description	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. 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		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. 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
All Cause Mortality
	Ultrasonography		Fiberoptic Bronchoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/98 (0%)
Serious Adverse Events
	Ultrasonography		Fiberoptic Bronchoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/97 (0%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	Ultrasonography		Fiberoptic Bronchoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/97 (34%)		29/98 (29.6%)
Cardiac disorders
Hypotension	33/97 (34%)	33	29/98 (29.6%)	29
Desaturation	16/97 (16.5%)	16	11/98 (11.2%)	11

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.