Video Double-Lumen Tube Prospective Randomized Study
Prospective Randomized Study on Video Double-Lumen Tube Versus Double-Lumen Tube
2 other identifiers
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2020
CompletedResults Posted
Study results publicly available
March 29, 2022
CompletedMarch 29, 2022
March 1, 2022
5.3 years
April 24, 2015
January 7, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
1 Day
Dislodgement During Positioning and Surgery
During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour
Study Arms (2)
Non-Video Double Lumen Tube (DLT) Group
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Participant receives non-video double lumen tube (DLT) placement before surgery.
Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.
Participant receives video double lumen tube (VDLT) placement before surgery.
Eligibility Criteria
You may qualify if:
- Patients need lung isolation for purposed surgery
- years or older
- All patients to give written informed consent to participate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- E.T. View Medical Ltdcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Results Point of Contact
- Title
- Jagtar S Heir, Professor, Anesthesiology & PeriOper Med
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jagtar S. Heir, DO
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2015
First Posted
April 29, 2015
Study Start
September 1, 2015
Primary Completion
December 18, 2020
Study Completion
December 18, 2020
Last Updated
March 29, 2022
Results First Posted
March 29, 2022
Record last verified: 2022-03