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

July 13, 2022 updated by: Hansu Bae

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Geyonggi-do
      • Goyang-si, Geyonggi-do, Korea, Republic of, 10323
        • Recruiting
        • Dongguk University Il-san hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of 3-cuffed double lumen tube inserted in lateral position
Time Frame: 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.
During procedure(Immediately after secondary intubation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hansu Bae

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Anticipated)

April 29, 2023

Study Completion (Anticipated)

April 29, 2023

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankor-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

This study is multi center observational study and we will not share any patients data with other center

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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