Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation

Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846936
• Other study ID #: AJIRB-DEV-DE1012-001
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: June 22, 2015
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumothorax

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyung Gi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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)	Yes