Lung DiseasesNCT03314519

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

A study testing Lung ultrasonography by experienced anaesthesiologist and Fiberoptic bronchoscopy for double lumen tube's position in people with Lung Diseases and Ultrasonography, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Diseases, Ultrasonography, Fiberoptic Bronchoscopy
What is being tested?: Lung ultrasonography by experienced anaesthesiologist and Fiberoptic bronchoscopy for double lumen tube's position
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteThailand
Study dates: 20 Oct 2017to 31 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Mahidol University
Bangkok Noi, Bangkok, 10700

Other trials in Thailand

About this study

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

Read the 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.

Conditions: Lung Diseases, Ultrasonography, Fiberoptic Bronchoscopy, One Lung Ventilation, Thoracic Surgery, Lung Collapse
Being tested: Lung ultrasonography by experienced anaesthesiologist, Fiberoptic bronchoscopy for double lumen tube's position
Keywords: Lung ultrasonography, Lung collapse, fiberoptic bronchoscopy, double lumen tube, compare, one lung ventilation, thoracic surgery, thoracic anaesthesia, lung ultrasound
Medical subject headings: Lung Diseases, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lung ultrasonography by experienced anaesthesiologistDiagnostic 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 for double lumen tube's positionDiagnostic 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

Study groups in NCT03314519
Study group	Role	What they receive
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. Receives: 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. Receives: Diagnostic Test: Fiberoptic bronchoscopy for double lumen tube's position

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30 minutes

Secondary outcomes (2)

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)
Measured: 30 minutes
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
Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 201731 Jul 2019

First posted19 Oct 2017
Study start20 Oct 2017
Primary completion10 Jul 2019
Study completion31 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Lung DiseasesStudies of the same condition, open and under way.
More trials run by Mahidol UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03314519
Sponsor's protocol ID: Skanavitoon
Status last verified: Mar 2020
First submitted: 15 Oct 2017
Last updated: 12 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 27138896
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.
PubMed 9805696
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.
PubMed 25149114
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.
PubMed 17021522
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.
PubMed 26379290
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.
PubMed 27053795
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.
PubMed 18456211
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.
PubMed 23513327
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.
PubMed 24662376
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.
PubMed 31333372
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.
PubMed 26257857
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.
PubMed 24432174
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.
PubMed 26474994
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.
PubMed 21802958
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.
PubMed 25711517

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study Compare Lung Ultrasonography to Fiberoptic Bronchoscopy Confirming Double Lumen Tube Positioning for Thoracic Surgery.
ClinicalTrials.gov ID: NCT03314519
Acronym / sponsor ID: Skanavitoon
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: 20 Oct 2017 (actual)
Primary completion: 10 Jul 2019 (actual)
Study completion: 31 Jul 2019 (actual)
First posted: 19 Oct 2017 (actual)
Results: Posted 12 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.

Arm	Type	Receives
Ultrasonography	Experimental	Diagnostic Test: Lung ultrasonography by experienced anaesthesiologistPatients 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.
Fiberoptic bronchoscopy	Active comparator	Diagnostic Test: Fiberoptic bronchoscopy for double lumen tube's positionPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lung ultrasonography by experienced anaesthesiologistUse ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard	Diagnostic test	Ultrasonography
Fiberoptic bronchoscopy for double lumen tube's positionUse 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	Diagnostic test	Fiberoptic bronchoscopy

Primary outcome

Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy
Time frame: 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

2 secondary outcomes

Timing to Detect Lung Collapse
Time frame: 30 minutes
Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow
Time frame: 30 minutes

Results and safety

Results posted to the registry on 12 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasonography	100	97
Fiberoptic Bronchoscopy	100	98

Primary outcome: Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy

Time frame: 30 minutes. Count of participants. Unit: Participants

Measure	Ultrasonography n = 97	Fiberoptic Bronchoscopy n = 98
Value	89	83

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Total intraoperative period, an average of 1 hour. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrasonography	0 of 97 (0%)	33 of 97 (34%)	0 of 97
Fiberoptic Bronchoscopy	0 of 98 (0%)	29 of 98 (29.6%)	0 of 98

Limitations and caveats (from the sponsor): Ultrasonographer needs to be completely blind due to clinical visualization of chest rising after intubation before and during perform ultrasonography.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27138896Bussieres 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.
Background: PubMed 9805696Boucek 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.
Background: PubMed 25149114Alvarez-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.
Background: PubMed 17021522Cohen 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.
Background: PubMed 26379290Parab 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.
Background: PubMed 27053795Diaz 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.
Background: PubMed 18456211Lohser 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.
Background: PubMed 23513327Kitabjian 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.
Background: PubMed 24662376Acosta 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.
Background: PubMed 31333372Yamaguchi 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.
Background: PubMed 26257857Nam 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.
Background: PubMed 24432174Saporito 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kasana Raksamani, MD principal investigator

Siriraj Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314519, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.