Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation

NCT ID: NCT01846936

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

DLT with conventional technique

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

BB with conventional technique

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Disconnection technique

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Sung Yong Park

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Yong Park, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University

Locations

Ajou University Hospital

Suwon, Gyung Gi, South Korea

Countries

South Korea

Other Identifiers

AJIRB-DEV-DE1012-001

Identifier Type: -

Identifier Source: org_study_id