Lung DiseasesNCT05462275
Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube
A study testing Intubation using 3-cuffed double lumen endotracheal tube in people with Lung Diseases, run by Hansu Bae at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Intubation using 3-cuffed double lumen endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2022to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dongguk University Il-san hospital
Goyang-si, Geyonggi-do, 10323
Hansu Bae, 082-010-6326-1641, hsbae81@gmail.com
Dongkyu Lee, 082-010-6431-4217, entopic@naver.com
About this study
Official title: Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube : Multi-center Observational Study
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.
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- Intubation using 3-cuffed double lumen endotracheal tube
- Keywords
- 3-cuffed double lumen tube, one lung ventilation, lung isolation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation using 3-cuffed double lumen endotracheal tubeDevice
After patient's position, 3-cuffed double lumen endotracheal tube is intubated without fiberoptic bronchoscopy guidance
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | There is only one group to evaluate this observational study. Receives: Device: Intubation using 3-cuffed double lumen endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure(Immediately after secondary intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start29 Apr 2022
- Primary completion29 Apr 2023 (estimated)
- Study completion29 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansu Bae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hansu Bae, Dongguk University International Hospital
- Investigators
- Dongkyu Lee, Study chair, Department of anesthesiology, Dongguk University Il-san hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462275
- Sponsor's protocol ID
- Ankor-1
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is multi center observational study and we will not share any patients data with other center
Publications
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.
PubMed 32430201Boisen 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.
PubMed 34053812Seo 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.
PubMed 31415423Kim 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.
PubMed 32244659Ball 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.
PubMed 6778119
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube : Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT05462275
- Acronym / sponsor ID
- Ankor-1
- Conditions
- Lung Diseases
- Keywords
- 3-cuffed double lumen tube, one lung ventilation, lung isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Hansu BaeUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 29 Apr 2023 (estimated)
- Study completion
- 29 Apr 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Intubation using 3-cuffed double lumen endotracheal tubeThere is only one group to evaluate this observational study. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Patients who are predicted difficult intubation
- Patients who is under upper airway infection
- Patients who have coagulopathy
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intubation using 3-cuffed double lumen endotracheal tubeAfter patient's position, 3-cuffed double lumen endotracheal tube is intubated without fiberoptic bronchoscopy guidance | Device | Test group |
Primary outcome
Success rate of 3-cuffed double lumen tube inserted in lateral position
Time frame: During procedure(Immediately after secondary intubation)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 32430201Boisen 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.
- Background: PubMed 34053812Boisen 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.
- Background: PubMed 31415423Seo 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.
- Background: PubMed 32244659Kim 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.
- Background: PubMed 6778119Ball 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.
- Individual participant dataSharing planned: No. This study is multi center observational study and we will not share any patients data with other center
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongkyu Lee study chair
Department of anesthesiology, Dongguk University Il-san hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation using 3-cuffed double lumen endotracheal tube in people with Lung Diseases, run by Hansu Bae at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hansu Bae (082-010-6326-1641, hsbae81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of 3-cuffed double lumen tube inserted in lateral position (time frame: During procedure(Immediately after secondary intubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462275, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.