Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube
Primary Purpose
Lung Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intubation using 3-cuffed double lumen endotracheal tube
Sponsored by
About this trial
This is an interventional health services research trial for Lung Diseases focused on measuring 3-cuffed double lumen tube, one lung ventilation, lung isolation
Eligibility Criteria
Inclusion Criteria:
- Adults who is including in ASA class I or II
- Patients scheduled for right lung surgery under right lung isolation
- Patients who don't have any anatomical variations in pulmonary system
- Patients who have never gotten a lung surgery
Exclusion Criteria:
- Pregnancy
- Patients who are predicted difficult intubation
- Patients who is under upper airway infection
- Patients who have coagulopathy
- Emergency surgery
- In addition, patients considered inappropriate to participate in this study
Sites / Locations
- Dongguk University Il-san hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test group
Arm Description
There is only one group to evaluate this observational study.
Outcomes
Primary Outcome Measures
Success rate of 3-cuffed double lumen tube inserted in lateral position
Authors insert 3-cuffed double lumen tube after position change to left lateral decubitus with blind fashion. At this time, probability that the tube will be inserted to an appropriate depth is primary endpoint.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05462275
Brief Title
Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube
Official Title
Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube : Multi-center Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
April 29, 2023 (Anticipated)
Study Completion Date
April 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hansu Bae
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Triple-cuffed double lumen endotracheal tube (TC-DLT, ANKOR tube. Insung corp., Korea) which was developed to isolate lung without endotracheal bronchoscope guidance has additional carinal cuff placed between bronchial tube cuff and tracheal tube cuff. This device has been successfully used to isolate lung more simply in specific settings when there is too much excretion to visualize endotracheal structure or for a health provider who is not good at use of traditional double-lumen tube. Although TC-DLT is designed to enable lung separation effectively in situations that confirmation of tube position using bronchoscopy is difficult or not available, but no studies have been conducted on whether effective lung isolation using TC-DLT is possible after change in the relative position of the bronchial tree by postural change. This plan was prepared for research on this.
Detailed Description
After enter into operating room, induction of anesthesia is performed through standard general anesthesia procedure before endotracheal intubation. Endotracheal intubation is performed using TC-DLT and inflate carinal cuff with 5 ~ 15ml of air. Then, push it into trachea until resistance is felt. When carinal cuff is placed at carina, deflate carinal cuff and isolate independent lung followed by confirmation of bronchial cuff position using fiberoptic bronchoscopy.
Record the location of the bronchial balloon in one of the following conditions
at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) :
proximal end of bronchial balloon is placed more of 5mm distally from carinal opening
proximal end of bronchial balloon is placed more of 5mm proximally from carinal opening
Then, change patient position to left lateral decubitus (LLD) position and check the position of bronchial balloon using fiberoptic bronchoscopy as previously done.
at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) :
proximal end of bronchial balloon is placed more of 5mm distally from carinal opening
proximal end of bronchial balloon is placed more of 5mm proximally from carinal opening
After check whether there is something to considerate, end this case.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
3-cuffed double lumen tube, one lung ventilation, lung isolation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional observational study. The investigators conduct this study to analyze the impact of patient position on the success in placing triple-cuffed double lumen endotracheal tube.
Masking
None (Open Label)
Masking Description
This study don't require any types of masking.
Allocation
N/A
Enrollment
167 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
There is only one group to evaluate this observational study.
Intervention Type
Device
Intervention Name(s)
Intubation using 3-cuffed double lumen endotracheal tube
Intervention Description
After patient's position, 3-cuffed double lumen endotracheal tube is intubated without fiberoptic bronchoscopy guidance
Primary Outcome Measure Information:
Title
Success rate of 3-cuffed double lumen tube inserted in lateral position
Description
Authors insert 3-cuffed double lumen tube after position change to left lateral decubitus with blind fashion. At this time, probability that the tube will be inserted to an appropriate depth is primary endpoint.
Time Frame
During procedure(Immediately after secondary intubation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults who is including in ASA class I or II
Patients scheduled for right lung surgery under right lung isolation
Patients who don't have any anatomical variations in pulmonary system
Patients who have never gotten a lung surgery
Exclusion Criteria:
Pregnancy
Patients who are predicted difficult intubation
Patients who is under upper airway infection
Patients who have coagulopathy
Emergency surgery
In addition, patients considered inappropriate to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hansu Bae
Phone
082-010-6326-1641
Email
hsbae81@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongkyu Lee
Phone
082-010-6431-4217
Email
entopic@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongkyu Lee
Organizational Affiliation
Department of anesthesiology, Dongguk University Il-san hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dongguk University Il-san hospital
City
Goyang-si
State/Province
Geyonggi-do
ZIP/Postal Code
10323
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hansu Bae
Phone
082-010-6326-1641
Email
hsbae81@gmail.com
First Name & Middle Initial & Last Name & Degree
Dongkyu Lee
Phone
082-010-6431-4217
Email
entopic@naver.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This study is multi center observational study and we will not share any patients data with other center
Citations:
PubMed Identifier
32430201
Citation
Boisen ML, Schisler T, Kolarczyk L, Melnyk V, Rolleri N, Bottiger B, Klinger R, Teeter E, Rao VK, Gelzinis TA. The Year in Thoracic Anesthesia: Selected Highlights from 2019. J Cardiothorac Vasc Anesth. 2020 Jul;34(7):1733-1744. doi: 10.1053/j.jvca.2020.03.016. Epub 2020 Apr 18. Erratum In: J Cardiothorac Vasc Anesth. 2021 Jan;35(1):343.
Results Reference
background
PubMed Identifier
34053812
Citation
Boisen ML, Fernando RJ, Kolarczyk L, Teeter E, Schisler T, La Colla L, Melnyk V, Robles C, Rao VK, Gelzinis TA. The Year in Thoracic Anesthesia: Selected Highlights From 2020. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2855-2868. doi: 10.1053/j.jvca.2021.04.012. Epub 2021 Apr 17.
Results Reference
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PubMed Identifier
31415423
Citation
Seo Y, Kim N, Paik HC, Park D, Oh YJ. Successful blind lung isolation with the use of a novel double-lumen endobronchial tube in a patient undergoing lung transplantation with massive pulmonary secretion: A case report. Medicine (Baltimore). 2019 Aug;98(33):e16869. doi: 10.1097/MD.0000000000016869.
Results Reference
background
PubMed Identifier
32244659
Citation
Kim N, Byon HJ, Kim GE, Park C, Joe YE, Suh SM, Oh YJ. A Randomized Controlled Trial Comparing Novel Triple-Cuffed Double-Lumen Endobronchial Tubes with Conventional Double-Lumen Endobronchial Tubes for Lung Isolation. J Clin Med. 2020 Apr 1;9(4):977. doi: 10.3390/jcm9040977.
Results Reference
background
PubMed Identifier
6778119
Citation
Ball WS, Wicks JD, Mettler FA Jr. Prone-supine change in organ position: CT demonstration. AJR Am J Roentgenol. 1980 Oct;135(4):815-20. doi: 10.2214/ajr.135.4.815.
Results Reference
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Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube
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