Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube

NCT05462275 | Unknown

• 1 other identifier: Ankor-1
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

3-cuffed double lumen tube; one lung ventilation; lung isolation

Outcome Measures

Primary Outcomes (1)

• 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.

  During procedure(Immediately after secondary intubation)

Study Arms (1)

Test group

EXPERIMENTAL

There is only one group to evaluate this observational study.

Device: Intubation using 3-cuffed double lumen endotracheal tube

Interventions

Intubation using 3-cuffed double lumen endotracheal tube DEVICE

After patient's position, 3-cuffed double lumen endotracheal tube is intubated without fiberoptic bronchoscopy guidance

Test group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansu Bae: lead

Study Sites (1)

Dongguk University Il-san hospital

Goyang-si, Geyonggi-do, 10323, South Korea

RECRUITING

Related Publications (5)

• 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.

  PMID: 32430201 BACKGROUND

• 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.

  PMID: 34053812 BACKGROUND

• 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.

  PMID: 31415423 BACKGROUND

• 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.

  PMID: 32244659 BACKGROUND

• 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.

  PMID: 6778119 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Dongkyu Lee

  Department of anesthesiology, Dongguk University Il-san hospital

  STUDY CHAIR

Central Study Contacts

Hansu Bae

CONTACT

082-010-6326-1641; hsbae81@gmail.com

Dongkyu Lee

CONTACT

082-010-6431-4217; entopic@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study don't require any types of masking.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 18, 2022
• Study Start: April 29, 2022
• Primary Completion: April 29, 2023
• Study Completion: April 29, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)