Video Double-Lumen Tube Prospective Randomized Study

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 3

Conditions: Other Surgical Procedures

Treatments: Device: Non-Video Double Lumen Tube (DLT); Device: Video Double Lumen Tube (VDLT); Procedure: Fiberoptic Bronchoscopy (FOB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02429414

2014-0991

NCI-2015-01551 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

83 participants in 2 patient groups

Non-Video Double Lumen Tube (DLT) Group

Experimental group

Description:

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).

Treatment:

Procedure: Fiberoptic Bronchoscopy (FOB)

Device: Non-Video Double Lumen Tube (DLT)

Video Double Lumen Tube (VDLT) Group

Experimental group

Description:

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.

Treatment:

Device: Video Double Lumen Tube (VDLT)