- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644642
Utility of Disconnection Technique for One Lung Ventilation
November 4, 2018 updated by: Go Un Roh, Ajou University School of Medicine
Utility of Disconnection Technique for One Lung Ventilation: a Comparison of a Double Lumen Endobronchial Tube With a Bronchial Blocker
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled for wedge resection for pneumothorax, unilateral
- ASA class I, II
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DLT(Double Lumen Tube) group
disconnection technique will be applied
|
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.
|
|
Experimental: BB(Bronchial Blocker) group
disconnection technique will be applied
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung deflation score
Time Frame: 10 min after inflation of balloon
|
verbal analog scale(0=no deflation, 10=complete deflation)
|
10 min after inflation of balloon
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
time for initial placement
Time Frame: from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute
|
from beginning of intubation until confirmation of adequate placement with bronchoscope, approximately 5 minute
|
|
time for lung deflation
Time Frame: from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min
|
from turning the ventilator off until the carbon dioxide reach to zero on capnography, within 2 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Go Un Roh, MD, Ajou University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
December 27, 2015
First Submitted That Met QC Criteria
December 30, 2015
First Posted (Estimate)
January 1, 2016
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 4, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-MED-DEO-15-391
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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