Clinical trial NCT02429414: Video Double-Lumen Tube Prospective Randomized Study
Official title: Prospective Randomized Study on Video Double-Lumen Tube Versus Double-Lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Other Surgical Procedures
Keywords: Surgical Procedure
Fiberoptic bronchoscopy
FOB
Non-Video Double Lumen Tube
DLT
Video Double Lumen Tube
VDLT
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: E.T. View Medical Ltd
First posted: 2015-04-29
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation
timeFrame: During surgery (from induction to extubation), an average of 1 hour
Secondary outcomes:
measure: Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System
timeFrame: During surgery (from induction to extubation), an average of 1 hour
measure: Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff
timeFrame: 1 Day
measure: Dislodgement During Positioning and Surgery
timeFrame: During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jagtar S. Heir, DO
role: PRINCIPAL_INVESTIGATOR
References: