Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation

A Randomized, Prospective Trial Comparing Double-lumen Tube and Bronchial Blocker With or Without Modified Disconnection Technique

One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial blocker (BB). In this study, the investigators compared the effectiveness of lung collapse using DLT, BB with spontaneous collapse, and BB with disconnection technique.

Study Overview

• Status: Completed
• Conditions: Pneumothorax
• Intervention / Treatment: Procedure: DLT with conventional technique; Procedure: BB with conventional technique; Procedure: Disconnection technique

Detailed Description

In selecting this maneuver of OLV, lung collapse is a major concern because it permits adequate surgical exposure. Although once lung deflation was achieved, the overall clinical performance appears to be similar, BB takes longer to deflate the operative lung and there is some conflict reports as to BB provides a similar degree of lung deflation compared to that of DLT.

The aim of this study was to compare the efficacy of BB and DLT for achieving lung collapse, and to evaluate the efficacy of disconnection technique with monitoring the carbon dioxide trace on a capnograph in BB. The investigators further evaluated the disconnection time, which is the time to loss of carbon dioxide trace on the capnograph, needed to facilitate lung collapse.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyung Gi
    • Suwon, Gyung Gi, Korea, Republic of, 443-721
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing thoracic surgery for which OLV is required

Exclusion Criteria:

• Patients with an anticipated difficult intubation with infectious or bleeding lung lesions are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLT with conventional technique; The double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered. One lung ventilation is initiated after the lumen of operative lung is clamped and opened.	Procedure: DLT with conventional technique; The double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered.
Active Comparator: BB with conventional technique; The brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under fiberoptic bronchoscopy (FOB) vision by turning the device's steering wheel. The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation. And then, dependent lung is ventilated.	Procedure: BB with conventional technique; The brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under FOB vision by turning the device's steering wheel. The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation.
Active Comparator: Disconnection technique; Disconnection technique; 1) before initiating OLV, we turned-off the ventilator and fully opened the adjustable pressure limiting valve allowing both lungs to collapse, and 2) after loss of the carbon dioxide trace on the capnograph, 3) inflated the BB cuff with air, and 4) turned-on the ventilator allowing only dependent-lung reventilation.	Procedure: Disconnection technique; Disconnection technique 1) deflate of the blocker cuff, 2) turn-off the ventilator and opened the APL valve allowing both lungs to collapse, 3) after loss of carbon dioxide trace in the capnograph, reinflate blocker cuff with the same volume of air as during the initial insertion, 4) reconnect the tube to the ventilator allowing only dependent-lung reventilation with a 5 cmH2O positive end-expiratory pressure preceded by a single recruitment maneuver performed by elevating the airway pressure to 40 cmH2O for 7 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of three lung isolation methods	The degree of lung collapse after 5 min from the start of OLV. The degree of lung collapse was assessed using a lung collapse score (0 = no collapse, to 10 = complete collapse) by one thoracic surgeon. The surgeon who assessed the lung collapse was absent from the operating room during DLT or BB placement and was blinded to the airway device.	Five min from the start of one lung ventilation
Effectiveness of three lung isolation methods	The degree of lung collapse after 5 min from the start of OLV. The degree of lung collapse was assessed using a lung collapse score (0 = no collapse, to 10 = complete collapse) by one thoracic surgeon. The surgeon who assessed the lung collapse was absent from the operating room during DLT or BB placement and was blinded to the airway device.	Ten min from the start of one lung ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The disconnection time	Before initiating OLV in group 3, we turned-off the ventilator and fully opened the adjustable pressure limiting valve allowing both lungs to collapse. And then, the time which capnograph lose the carbon dioxide curve is considered the disconnection time required for both lungs to collapse before initiating one lung ventilation.	The time to loss the carbon dioxide trace on the capnograph (30 seconds)

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Sung Yong Park, MD, Ajou University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: efficacy; one lung ventilation; bronchial blocker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: AJIRB-DEV-DE1012-001