NCT02429414

Video Double-Lumen Tube Prospective Randomized Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Other Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Non-Video Double Lumen Tube (DLT)	Participant receives non-video double lumen tube (DLT) placement before surgery.
PROCEDURE	Fiberoptic Bronchoscopy (FOB)	Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.
DEVICE	Video Double Lumen Tube (VDLT)	Participant receives video double lumen tube (VDLT) placement before surgery.

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-12-18
• Completion: 2020-12-18
• First posted: 2015-04-29
• Last updated: 2022-03-29
• Results posted: 2022-03-29

Locations

1 site across 1 country: United States