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Completed

NCT Number: NCT01846936

Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation

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.

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Key information

Conditions

Pneumothorax Pleural Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyung Gi, 443-721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Effectiveness of three lung isolation methods

    Time frame: Five min from the start of one lung ventilation

    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.

  2. Effectiveness of three lung isolation methods

    Time frame: Ten min from the start of one lung ventilation

    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.

Secondary outcomes

  1. The disconnection time

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

    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.

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 6, 2013
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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