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

NCT ID: NCT05462275

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-29

Study Completion Date

2023-04-29

Brief Summary

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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

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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

1. at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) :
2. proximal end of bronchial balloon is placed more of 5mm distally from carinal opening
3. 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.

1. at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) :
2. proximal end of bronchial balloon is placed more of 5mm distally from carinal opening
3. 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

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Lung Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

This study don't require any types of masking.

Study Groups

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Test group

There is only one group to evaluate this observational study.

Group Type EXPERIMENTAL

Intubation using 3-cuffed double lumen endotracheal tube

Intervention Type DEVICE

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

Interventions

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Intubation using 3-cuffed double lumen endotracheal tube

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hansu Bae

OTHER

Sponsor Role lead

Responsible Party

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Hansu Bae

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dongkyu Lee

Role: STUDY_CHAIR

Department of anesthesiology, Dongguk University Il-san hospital

Locations

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Dongguk University Il-san hospital

Goyang-si, Geyonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hansu Bae

Role: CONTACT

082-010-6326-1641

Dongkyu Lee

Role: CONTACT

082-010-6431-4217

Facility Contacts

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Hansu Bae

Role: primary

082-010-6326-1641

Dongkyu Lee

Role: backup

082-010-6431-4217

References

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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.

Reference Type BACKGROUND
PMID: 32430201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34053812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31415423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32244659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6778119 (View on PubMed)

Other Identifiers

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Ankor-1

Identifier Type: -

Identifier Source: org_study_id

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