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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462275
• Other study ID #: Ankor-1
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: April 29, 2023

Study information

• Verified date: July 2022
• Source: Dongguk University International Hospital
• Contact: Hansu Bae
• Phone: 082-010-6326-1641
• Email: hsbae81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: April 29, 2023
• Est. primary completion date: April 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• Intubation using 3-cuffed double lumen endotracheal tube
After patient's position, 3-cuffed double lumen endotracheal tube is intubated without fiberoptic bronchoscopy guidance

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Il-san hospital	Goyang-si	Geyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hansu Bae

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. Review. — View 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. Review. Erratum in: J Cardiothorac Vasc Anesth. 2021 Jan;35(1):343. — View 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). pii: E977. doi: 10.3390/jcm9040977. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)