A Clinical Comparison of Two New Bronchial Blockers vs. Double Lumen Tubes in One Lung Ventilation

NCT02983149 | Completed

• 1 other identifier: 14-7478-A
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing thoracic surgery require selective ventilation of one lung, which allows surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are in routine clinical use at University Health Network. Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design and two balloons, one of which is designed to fall into each of the right and left sides, it may require less repositioning. Initial clinical experience with the EZ Blocker suggests that it may be less likely than other blockers to become malpositioned during surgery. This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker at this institution, and to double-lumen tubes, the most commonly used devices to provide lung isolation, with respect to intra-operative malpositioning and the speed of lung separation and efficacy of lung collapse during thoracic surgery. Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or left-sided DLT, immediately prior to induction of anesthesia. The primary end points of time to lung isolation and number of required repositioning maneuvers.

Conditions

Thoracic Surgery, Lung Isolation

Outcome Measures

Primary Outcomes (3)

• Time required for lung separation

  The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation.

  From initial laryngoscopy to lung isolation will be measured for 0 hours (procedure start) to 3 hours (procedure end time)

• Number of repositioning maneuvers of the device

  The number of repositions of the lung isolation device after initial supine placement

  After initial patient's supine position for the duration of the operation 0-3 hours will be recorded

• Lung collapse scores

  Time Frame: After opening the pleura, the lung collapse scores will be measured at 0, 10 and 20 minutes (from pleura opening)

  The thoracic surgeons, using a verbal analogue scale, will be assessing the lung collapse score (LCS), from 0=no collapse to 10=complete collapse. LCS will be assessed just after opening the pleura, at 10 min., and 20 min. after opening the pleura.

Study Arms (3)

Double lumen tube

OTHER

One lung ventilation will be achieved using a double lumen tube

Device: Double lumen tube

Fuji blocker

OTHER

One lung ventilation will be achieved using the Fuji blocker

Device: Fuji blocker

EZ blocker

OTHER

One lung ventilation will be achieved using the EZ blocker

Device: EZ blocker

Interventions

Double lumen tube DEVICE

Use an double lumen tube to achieve one lung ventilation in thoracic surgeries

Double lumen tube

Fuji blocker DEVICE

Use the Fuji blocker to achieve one lung ventilation in thoracic surgeries

Fuji blocker

EZ blocker DEVICE

Use the EZ blocker to achieve one lung ventilation in thoracic surgeries

EZ blocker

Eligibility Criteria

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

You may qualify if:

• Age \>18 years.
• Thoracic surgery requiring one-lung ventilation for \> 30 minutes.
• Able to provide first party consent.

You may not qualify if:

• Known prior difficult intubation.
• Upper airway exam suggestive of difficult intubation.
• Surgical procedure requiring a right double lumen endotracheal tube (such as left pneumonectomy).
• Evidence on clinically required radiologic imaging of abnormal lower airway anatomy, such as right upper lobe origin of the bronchus.
• Prior thoracic surgery or pleurodesis of the operative side (would delay lung collapse).
• History of severe restrictive lung disease (such as pulmonary fibrosis or emphysema) which may affect inflation/deflation times.
• Trauma patients requiring video-assisted thoracoscopic surgery
• Has condition(s) that contraindicate a double lumen endotracheal tube (DLT) or the placement of a bronchial blocker (BB) via a single lumen endotracheal tube.
• Patients with communication difficulties.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, 200 Elizabeth St.

Toronto, Ontario, B3H 1V7, Canada

Location

Study Officials

• Peter Slinger, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Anesthesia Research

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: December 6, 2016
• Study Start: December 10, 2015
• Primary Completion: July 31, 2019
• Study Completion: October 31, 2019
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)