Other Surgical ProceduresPhase 3NCT02429414

Video Double-Lumen Tube Prospective Randomized Study

A Phase 3 study testing Non-Video Double Lumen Tube (DLT), Fiberoptic Bronchoscopy (FOB) and Video Double Lumen Tube (VDLT) in people with Other Surgical Procedures, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Other Surgical Procedures
What is being tested?: Non-Video Double Lumen Tube (DLT), Fiberoptic Bronchoscopy (FOB) and Video Double Lumen Tube (VDLT)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: Sep 2015to 18 Dec 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Non-Video Double Lumen Tube (DLT), Fiberoptic Bronchoscopy (FOB), Video Double Lumen Tube (VDLT)
Keywords: Surgical Procedure, Fiberoptic bronchoscopy, FOB, Non-Video Double Lumen Tube, DLT, Video Double Lumen Tube, VDLT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-Video Double Lumen Tube (DLT)Device
Also called DLT
Participant receives non-video double lumen tube (DLT) placement before surgery.
Fiberoptic Bronchoscopy (FOB)Procedure or surgery
Also called FOB
Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.
Video Double Lumen Tube (VDLT)Device
Also called VDLT
Participant receives video double lumen tube (VDLT) placement before surgery.

Study groups in NCT02429414
Study group	Role	What they receive
Non-Video Double Lumen Tube (DLT) Group	Experimental	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). Receives: Device: Non-Video Double Lumen Tube (DLT); Procedure: Fiberoptic Bronchoscopy (FOB)
Video Double Lumen Tube (VDLT) Group	Experimental	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. Receives: Device: Video Double Lumen Tube (VDLT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: During surgery (from induction to extubation), an average of 1 hour

Secondary outcomes (3)

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.
Measured: 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
Measured: 1 Day
Dislodgement During Positioning and Surgery
Measured: During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201518 Dec 2020

First posted29 Apr 2015 (estimated)
Study startSep 2015
Primary completion18 Dec 2020
Study completion18 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Other Surgical ProceduresStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02429414
Sponsor's protocol ID: 2014-0991
Other IDs: NCI-2015-01551
Status last verified: Mar 2022
First submitted: 24 Apr 2015
Last updated: 29 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Study on Video Double-Lumen Tube Versus Double-Lumen Tube
ClinicalTrials.gov ID: NCT02429414
Acronym / sponsor ID: 2014-0991
Conditions: Other Surgical Procedures
Keywords: Surgical Procedure, Fiberoptic bronchoscopy, FOB, Non-Video Double Lumen Tube, DLT, Video Double Lumen Tube, VDLT
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: E.T. View Medical Ltd
Study start: Sep 2015 (actual)
Primary completion: 18 Dec 2020 (actual)
Study completion: 18 Dec 2020 (actual)
First posted: 29 Apr 2015 (estimated)
Results: Posted 29 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Non-Video Double Lumen Tube (DLT) Group	Experimental	Device: Non-Video Double Lumen Tube (DLT), Procedure: Fiberoptic Bronchoscopy (FOB)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).
Video Double Lumen Tube (VDLT) Group	Experimental	Device: Video Double Lumen Tube (VDLT)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

Patient with known tracheobronchial anatomical anomalies
Patient requiring emergency operations
Patients with known difficult airways
Patients where other lung isolation devices may be warranted (tracheostomy, nasal intubation)
Patient requiring sizes not available in DLT or VDLT

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-Video Double Lumen Tube (DLT)Also: DLTParticipant receives non-video double lumen tube (DLT) placement before surgery.	Device	Non-Video Double Lumen Tube (DLT) Group
Fiberoptic Bronchoscopy (FOB)Also: FOBFiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.	Procedure or surgery	Non-Video Double Lumen Tube (DLT) Group
Video Double Lumen Tube (VDLT)Also: VDLTParticipant receives video double lumen tube (VDLT) placement before surgery.	Device	Video Double Lumen Tube (VDLT) Group

Primary outcome

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

3 secondary outcomes

Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System
Time frame: 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
Time frame: 1 Day
Dislodgement During Positioning and Surgery
Time frame: During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour

Results and safety

Results posted to the registry on 29 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mallinckrodt Double Lumen Tube (DLT)	42	42
Vivasight Video Double Lumen Tube (VDLT)	38	37

Primary outcome: Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation

Time frame: During surgery (from induction to extubation), an average of 1 hour. Count of participants. Unit: Participants

Measure	Mallinckrodt Double Lumen Tube (DLT) n = 42	Vivasight Video Double Lumen Tube (VDLT) n = 38
Value	42	5

Mallinckrodt Double Lumen Tube (DLT) vs Vivasight Video Double Lumen Tube (VDLT): p <0.0001, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During surgery (from induction to extubation). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mallinckrodt Double Lumen Tube (DLT)	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Vivasight Video Double Lumen Tube (VDLT)	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Other Surgical Procedures

Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Not yet recruitingPhase 2
A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
Early-Stage Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.
Carcinoma, Hepatocellular, Hepatocellular Cancer
RecruitingPhase 2
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Features
Non-small Cell Lung Cancer Stage III

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jagtar S. Heir, DO principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation (time frame: During surgery (from induction to extubation), an average of 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02429414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.