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

Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube : Multi-center Observational Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05462275
Enrollment
167
Registered
2022-07-18
Start date
2022-04-29
Completion date
2023-04-29
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Keywords

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

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 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.

Interventions

DEVICEIntubation using 3-cuffed double lumen endotracheal tube

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

Sponsors

Hansu Bae
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

This study don't require any types of masking.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate of 3-cuffed double lumen tube inserted in lateral positionDuring 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.

Countries

South Korea

Contacts

Primary ContactHansu Bae
hsbae81@gmail.com082-010-6326-1641
Backup ContactDongkyu Lee
entopic@naver.com082-010-6431-4217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026