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

Sponsor
Hansu Bae (Other)
Overall Status
Recruiting
CT.gov ID
NCT05462275
Collaborator
(none)
167
1
1
12
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intubation using 3-cuffed double lumen endotracheal tube
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
167 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Masking Description:
This study don't require any types of masking.
Primary Purpose:
Health Services Research
Official Title:
Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube : Multi-center Observational Study
Actual Study Start Date :
Apr 29, 2022
Anticipated Primary Completion Date :
Apr 29, 2023
Anticipated Study Completion Date :
Apr 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test group

There is only one group to evaluate this observational study.

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

Outcome Measures

Primary Outcome Measures

  1. Success rate of 3-cuffed double lumen tube inserted in lateral position [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dongguk University Il-san hospital Goyang-si Geyonggi-do Korea, Republic of 10323

Sponsors and Collaborators

  • Hansu Bae

Investigators

  • Study Chair: Dongkyu Lee, Department of anesthesiology, Dongguk University Il-san hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hansu Bae, Assistant professor, Dongguk University International Hospital
ClinicalTrials.gov Identifier:
NCT05462275
Other Study ID Numbers:
  • Ankor-1
First Posted:
Jul 18, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hansu Bae, Assistant professor, Dongguk University International Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022