NCT02644642

Brief Summary

Lung isolation technique is useful for lung or heart surgeries for better visualization. Double lumen endobronchial tube and bronchial blocker are available for lung isolation. Adding disconnection technique before lung isolation is helpful to accelerate the lung deflation. However, the utility of disconnection technique has never been evaluated in comparison of double lumen tube and bronchial blocker. Therefore, the utility of disconnection technique in two different lung isolation technique, double lumen tube and bronchial blocker will be evaluated

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

December 27, 2015

Last Update Submit

November 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lung deflation score

    verbal analog scale(0=no deflation, 10=complete deflation)

    10 min after inflation of balloon

Secondary Outcomes (2)

  • time for initial placement

    from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute

  • time for lung deflation

    from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min

Study Arms (2)

DLT(Double Lumen Tube) group

EXPERIMENTAL

disconnection technique will be applied

Other: disconnection technique

BB(Bronchial Blocker) group

EXPERIMENTAL

disconnection technique will be applied

Other: disconnection technique

Interventions

Before lung isolation, the ventilator stays switched-off until the carbon dioxide on the capnogram reached to zero. Then, inflate the balloon either on the double lumen tube or on the bronchial blocker.

BB(Bronchial Blocker) groupDLT(Double Lumen Tube) group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients scheduled for wedge resection for pneumothorax, unilateral
  • ASA class I, II

You may not qualify if:

  • know lung disease
  • any kind of lung abnormality on preoperative chest x-ray
  • coronary artery occlusive disease
  • cerebrovascular disease
  • pregnancy
  • unable to understand the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Go Un Roh, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 27, 2015

First Posted

January 1, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 6, 2018

Record last verified: 2018-11