Phase 3
N=80
Video Double-Lumen Tube Prospective Randomized Study
Other Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT02429414 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation — 42; 5 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Non-Video Double Lumen Tube (DLT) (Device); Fiberoptic Bronchoscopy (FOB) (Procedure); Video Double Lumen Tube (VDLT) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation |
42; 5 | <0.0001 sig |
| SECONDARY Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System |
42; 33; 0; 5; 0; 0 | 0.0209 sig |
| SECONDARY Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff |
2; 7 | 0.078 |
| SECONDARY Dislodgement During Positioning and Surgery |
9; 8; 3; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients need lung isolation for purposed surgery
- 18 years or older
- All patients to give written informed consent to participate
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02429414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.