EZ-blocker Versus Left Sided Double Lumen Tube in Adult Patients for Thoracic Surgery

NCT03403192 | Completed Results FDA Device

• 1 other identifier: IRB00038220
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the positional stability and quality of lung isolation provided by the EZ-blocker compared to a DLT for both right and left sided thoracic surgery. An additional objective will be to assess time to placement of both devices and other significant clinical differences between these two approaches to placement of the bronchial blocker (BB) including airway injury and post-operatives sore throat, post-operative hoarseness, Additionally we would like to examine the preoperative high resolution CT imaging data to determine if there are anatomic landmarks that may potentially inform the appropriateness or inappropriateness of choosing an EZ-blocker or left sided DLT.

Conditions

Thoracic Injuries

Keywords

EZ Blocker; DLT; Double Lumen Tube; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Double Lumen Tube (DLT) or Bronchial Blocker (BB) Replacements

  Positional stability of lung isolation by measuring number of replacements due to device moving too deep or too shallow (proximal) within the lung.

  End of surgical procedure

Secondary Outcomes (3)

• Time it Takes to Place for Double Lumen Tube (DLT) and EZ

  End of surgical procedure

• Quality of Lung Isolation Between Devices

  End of surgical procedure

• Side Effects of Devices

  2 days post operation

Study Arms (4)

EZ-Blocker in the left lung

ACTIVE COMPARATOR

This arm will receive the EZ-Blocker in the left lung of their body, which functions as a bronchial blocker.

Device: EZ-Blocker

EZ-Blocker in right lung

ACTIVE COMPARATOR

This arm will receive the EZ-Blocker in the right lung of their body, which functions as a bronchial blocker.

Device: EZ-Blocker

DLT in left lung

ACTIVE COMPARATOR

This arm will receive the DLT in the left lung of their body, which functions as a bronchial blocker.

Device: DLT

DLT in right lung

ACTIVE COMPARATOR

This arm will receive the DLT in the right lung of their body, which functions as a bronchial blocker.

Device: DLT

Interventions

EZ-Blocker DEVICE

The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a "Y" configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation.

EZ-Blocker in right lung; EZ-Blocker in the left lung

DLT DEVICE

A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.

DLT in left lung; DLT in right lung

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients greater than 18 and 80 years of age scheduled for thoracoscopic surgery or thoracotomy requiring lung isolation
• Patient presenting as an outpatient for elective thoracic surgery
• In patients scheduled for thoracic surgery.

You may not qualify if:

• History of difficult airway/intubation
• Patients suspected to have a difficult airway.
• Morbid obesity BMI \>39
• Pregnancy
• Emergency status of surgery
• Thoracic surgery requiring a right sided double lumen tube

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (9)

• Mungroop HE, Wai PT, Morei MN, Loef BG, Epema AH. Lung isolation with a new Y-shaped endobronchial blocking device, the EZ-Blocker. Br J Anaesth. 2010 Jan;104(1):119-20. doi: 10.1093/bja/aep353. No abstract available.

  PMID: 20007802 BACKGROUND

• Dumans-Nizard V, Liu N, Laloe PA, Fischler M. A comparison of the deflecting-tip bronchial blocker with a wire-guided blocker or left-sided double-lumen tube. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):501-5. doi: 10.1053/j.jvca.2009.02.002. Epub 2009 Apr 10.

  PMID: 19362014 BACKGROUND

• Campos JH, Hallam EA, Van Natta T, Kernstine KH. Devices for lung isolation used by anesthesiologists with limited thoracic experience: comparison of double-lumen endotracheal tube, Univent torque control blocker, and Arndt wire-guided endobronchial blocker. Anesthesiology. 2006 Feb;104(2):261-6, discussion 5A. doi: 10.1097/00000542-200602000-00010.

  PMID: 16436844 BACKGROUND

• Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. doi: 10.1097/00000542-200609000-00009.

  PMID: 16931978 BACKGROUND

• Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2.

  PMID: 25753765 BACKGROUND

• Kus A, Hosten T, Gurkan Y, Gul Akgul A, Solak M, Toker K. A comparison of the EZ-Blocker with a Cohen Flex-Tip blocker for one-lung ventilation. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):896-9. doi: 10.1053/j.jvca.2013.02.006. Epub 2013 Aug 16.

  PMID: 23958073 BACKGROUND

• Mourisse J, Liesveld J, Verhagen A, van Rooij G, van der Heide S, Schuurbiers-Siebers O, Van der Heijden E. Efficiency, efficacy, and safety of EZ-blocker compared with left-sided double-lumen tube for one-lung ventilation. Anesthesiology. 2013 Mar;118(3):550-61. doi: 10.1097/ALN.0b013e3182834f2d.

  PMID: 23299364 BACKGROUND

• Piccioni F, Vecchi I, Spinelli E, Previtali P, Langer M. Extraluminal EZ-blocker Placement for One-lung Ventilation in Pediatric Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):e71-3. doi: 10.1053/j.jvca.2015.05.200. Epub 2015 May 27. No abstract available.

  PMID: 26342270 BACKGROUND

• Templeton TW, Downard MG, Simpson CR, Zeller KA, Templeton LB, Bryan YF. Bending the rules: a novel approach to placement and retrospective experience with the 5 French Arndt endobronchial blocker in children <2 years. Paediatr Anaesth. 2016 May;26(5):512-20. doi: 10.1111/pan.12882. Epub 2016 Mar 9.

  PMID: 26956889 BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Benjamin Morris, MD
• Organization: Wake Forest Health Science

bmorris@wakehealth.edu

336.716.6533

Study Officials

• Benjamin N Morris, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The surgeon will be blinded to technique and queried as to the quality of isolation upon entry into the chest and this will be recorded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The objective of this study is to evaluate the positional stability and quality of lung isolation provided by the EZ-blocker compared to a DLT for both right and left sided thoracic surgery

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: January 26, 2018
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2019-06

Locations

US (1)