Double Lumen Endotracheal Tube, Single Lung Ventilation
Conditions
Brief summary
This prospective, randomized, comparative study is intended to enroll a total of 50 patients undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will be recorded. The attending thoracic surgeon will judge the quality of lung deflation. The occurrence of any malposition and subsequent maneuvers will be recorded. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.
Interventions
Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-90 years old * Scheduled for a thoracic surgery that requires single lung ventilation * Willing and able to consent in English or Spanish
Exclusion criteria
* Age less than 18 or older than 90 * Patient does not speak English or Spanish * Patient refusal * Pregnant or nursing women * Known or suspected difficult airway * Contraindication for left sided double lumen tube (e.g, L bronchial mass)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Flexible Fiberoptic Bronchoscopy | Intraoperative, within the time the double lumen was in the trachea | The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Intubation Time | Intraoperative, time to successfully intubate patient. | The time required to place double lumen endotracheal tube for a single lung intubation |
| Number of Participants With Malposition | Intraoperative, within the time the double lumen was in the trachea | The number of participants with malposition of double lumen tube for a single lung intubation |
| The Cost of Double Lumen Tube Intubation | Intraoperative | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Double Lumen Tube Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery | 25 |
| VivaSight Double Lumen Tube Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Conventional Double Lumen Tube | VivaSight Double Lumen Tube | Total |
|---|---|---|---|
| Age, Continuous | 55 years | 57 years | 56 years |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 8 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 26 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants Requiring Flexible Fiberoptic Bronchoscopy
The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.
Time frame: Intraoperative, within the time the double lumen was in the trachea
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Double Lumen Tube | Number of Participants Requiring Flexible Fiberoptic Bronchoscopy | 25 Participants |
| VivaSight Double Lumen Tube | Number of Participants Requiring Flexible Fiberoptic Bronchoscopy | 7 Participants |
Secondary
Number of Participants With Malposition
The number of participants with malposition of double lumen tube for a single lung intubation
Time frame: Intraoperative, within the time the double lumen was in the trachea
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Double Lumen Tube | Number of Participants With Malposition | 12 Participants |
| VivaSight Double Lumen Tube | Number of Participants With Malposition | 4 Participants |
Secondary
The Cost of Double Lumen Tube Intubation
Time frame: Intraoperative
Population: This outcome was not measured and no data was collected due to lack of resources to conduct the analysis.
Secondary
The Intubation Time
The time required to place double lumen endotracheal tube for a single lung intubation
Time frame: Intraoperative, time to successfully intubate patient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Conventional Double Lumen Tube | The Intubation Time | 156 seconds |
| VivaSight Double Lumen Tube | The Intubation Time | 54 seconds |