Skip to main content
OpenTrials
Completed

NCT Number: NCT02429414

Video Double-Lumen Tube Prospective Randomized Study

The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of 2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube (called a non-video DLT). An FOB may or may not be performed, as described below.

The level of effectiveness of the VDLT and non-video DLT will be compared.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Other Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

The difference between the 2 types of breathing tubes is that the VDLT has a built-in camera that is designed to allow the doctor to see the airways continuously.

A fiberoptic scope is a thin device that may be placed into the breathing tube in order to check that the tube is in the correct place.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive a non-video DLT for lung isolation before surgery. Once the doctor thinks the non-video DLT is in the correct place, its final position before surgery will be checked with an FOB.

If you are in Group 2, you will receive a VDLT for lung isolation before surgery. Once the doctor thinks the VDLT is in the correct place, its final position before surgery will be checked with the camera inside the tube. However, if the doctor thinks it is needed, an FOB may also be used to confirm that the VDLT is in the correct place.

You will sign a separate consent form that describes the risks of surgery.

Procedures:

Once the doctor thinks the VDLT or non-video DLT is in the correct place and your lung(s) can be isolated, you will have surgery as planned. At the end of surgery, the breathing tube will be removed.

If the breathing tube cannot be placed, you will not have the surgery at that time.

Length of Study:

After the surgery, your study participation will be over.

This is an investigational study. The VDLT and non-video DLT are FDA approved and commercially available. Comparing them is investigational. The study doctor can explain how the study devices are designed to work.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients need lung isolation for purposed surgery
  • 18 years or older
  • All patients to give written informed consent to participate

Exclusion criteria

  • Patient with known tracheobronchial anatomical anomalies
  • Patient requiring emergency operations
  • Patients with known difficult airways
  • Patients where other lung isolation devices may be warranted (tracheostomy, nasal intubation)
  • Patient requiring sizes not available in DLT or VDLT
  • Patients requiring a right sided VDLT or DLT

Treatment and study plan

Non-Video Double Lumen Tube (DLT)

Device

Participant receives non-video double lumen tube (DLT) placement before surgery.

Other names: DLT

Fiberoptic Bronchoscopy (FOB)

Procedure

Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.

Other names: FOB

Video Double Lumen Tube (VDLT)

Device

Participant receives video double lumen tube (VDLT) placement before surgery.

Other names: VDLT

Primary outcomes

  1. Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation

    Time frame: During surgery (from induction to extubation), an average of 1 hour

    The rate of FOB use for the VDLT arm and the Double-Lumenendobronchial Tubes (DLT) arm was calculated. The Fisher's exact test or chi-square test was used to evaluate the association between 2 categorical variables. Wilcoxon rank-sum test was used to evaluate the difference in a continuous variable. Rate of fiberoptic use with the Video Double-Lumen Tube (VDLT) during surgeries requiring lung isolation and to compare to the rate of Fiberoptic Bronchoscopy (FOB) use with the conventional DLT.

Secondary outcomes

  1. Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System

    Time frame: During surgery (from induction to extubation), an average of 1 hour

    Good is defined as able to visualize all structures and good lung isolation position verified Adequate is defined as able to visualize primary carina, other structures challenging to visualize good lung isolation position verified Poor is defined as unable to recognize anatomy.

  2. Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff

    Time frame: 1 Day

  3. Dislodgement During Positioning and Surgery

    Time frame: During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • E.T. View Medical Ltd

Registry information

Official study title

Prospective Randomized Study on Video Double-Lumen Tube Versus Double-Lumen Tube

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2015
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.