Video Double-Lumen Tube Prospective Randomized Study

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

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.

Study Overview

• Status: Completed
• Conditions: Other Surgical Procedures
• Intervention / Treatment: Device: Non-Video Double Lumen Tube (DLT); Procedure: Fiberoptic Bronchoscopy (FOB); Device: Video Double Lumen Tube (VDLT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients need lung isolation for purposed surgery
2. 18 years or older
3. All patients to give written informed consent to participate

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Video Double Lumen Tube (DLT) Group; Participants receive a non-video DLT for lung isolation before surgery. Once non-video DLT is in correct place, its final position before surgery checked with a fiberoptic bronchoscopy (FOB).	Device: Non-Video Double Lumen Tube (DLT); Participant receives non-video double lumen tube (DLT) placement before surgery.; Other Names: DLT; Procedure: Fiberoptic Bronchoscopy (FOB); Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.; Other Names: FOB
Experimental: Video Double Lumen Tube (VDLT) Group; Participants receive a VDLT for lung isolation before surgery. Once VDLT is in correct place, its final position before surgery checked with the camera inside the tube.	Device: Video Double Lumen Tube (VDLT); Participant receives video double lumen tube (VDLT) placement before surgery.; Other Names: VDLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation	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.	During surgery (from induction to extubation), an average of 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System	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.	During surgery (from induction to extubation), an average of 1 hour
Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff		1 Day
Dislodgement During Positioning and Surgery		During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: E.T. View Medical Ltd
• Investigators: Principal Investigator: Jagtar S. Heir, DO, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Fiberoptic bronchoscopy; DLT; Surgical Procedure; FOB; Non-Video Double Lumen Tube; Video Double Lumen Tube; VDLT
• Other Study ID Numbers: 2014-0991; NCI-2015-01551 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No