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

NCT02983149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-05-04

No results posted yet for this study

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

Interventions

DEVICE

Double lumen tube

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

DEVICE

Fuji blocker

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

DEVICE

EZ blocker

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

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Peter Slinger, MD · Toronto General Hospital, University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-10
Primary Completion
2019-07-31
Completion
2019-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02983149 on ClinicalTrials.gov