ClinicalTrials.gov
ClinicalTrials.gov Menu

Video Double-Lumen Tube Prospective Randomized Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02429414
Recruitment Status : Active, not recruiting
First Posted : April 29, 2015
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
ET View Ltd, Misgav
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Other Surgical Procedures Device: Non-Video Double Lumen Tube (DLT) Procedure: Fiberoptic Bronchoscopy (FOB) Device: Video Double Lumen Tube (VDLT) Phase 3

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  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Study on Video Double-Lumen Tube Versus Double-Lumen Tube
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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 Name: DLT

Procedure: Fiberoptic Bronchoscopy (FOB)
Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.
Other Name: 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 Name: VDLT




Primary Outcome Measures :
  1. Rate of Fiberoptic Bronchoscopy (FOB) [ Time Frame: 1 day ]
    Rate of FOB use and its 95% confidence interval for the new video double lumen tube arm and the conventional double lumen tube arm calculated. Fisher's exact test or Chi-square test used to evaluate the difference in the rate of FOB use between the two arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429414


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
ET View Ltd, Misgav
Investigators
Principal Investigator: Jagtar S. Heir, DO M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02429414     History of Changes
Other Study ID Numbers: 2014-0991
NCI-2015-01551 ( Registry Identifier: NCI CTRP )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by M.D. Anderson Cancer Center:
Surgical Procedure
Fiberoptic bronchoscopy
FOB
Non-Video Double Lumen Tube
DLT
Video Double Lumen Tube
VDLT