Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation

NCT01846936 | Completed

• 1 other identifier: AJIRB-DEV-DE1012-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumothorax

Keywords

one lung ventilation; efficacy; bronchial blocker

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The disconnection time

  The time to loss the carbon dioxide trace on the capnograph (30 seconds)

Study Arms (3)

DLT with conventional technique

EXPERIMENTAL

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

BB with conventional technique

ACTIVE COMPARATOR

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

Disconnection technique

ACTIVE COMPARATOR

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

Interventions

DLT with conventional technique PROCEDURE

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.

DLT with conventional technique

BB with conventional technique PROCEDURE

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.

BB with conventional technique

Disconnection technique PROCEDURE

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.

Disconnection technique

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing thoracic surgery for which OLV is required

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyung Gi, 443-721, South Korea

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Sung Yong Park, MD

  Ajou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: May 6, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

KR (1)