Other Surgical Procedures
Conditions
Keywords
Surgical Procedure, Fiberoptic bronchoscopy, FOB, Non-Video Double Lumen Tube, DLT, Video Double Lumen Tube, VDLT
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.
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.
Interventions
DEVICENon-Video Double Lumen Tube (DLT)
Participant receives non-video double lumen tube (DLT) placement before surgery.
PROCEDUREFiberoptic Bronchoscopy (FOB)
Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.
DEVICEVideo Double Lumen Tube (VDLT)
Participant receives video double lumen tube (VDLT) placement before surgery.
Sponsors
E.T. View Medical Ltd
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: September 2015 - July 2016
Pre-assignment details
83 participants consented, 3 were not eligible due to (1) withdrew consent, (1) withdrawal by subject, and (1) physician's decision.
Participants by arm
| Arm | Count |
|---|---|
| Mallinckrodt Double Lumen Tube (DLT) 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). Non-Video Double Lumen Tube (DLT): Participant receives non-video double lumen tube (DLT) placement before surgery. Fiberoptic Bronchoscopy (FOB): Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT. Under General Anesthesia, the Double Lumen Tube (DLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations. | 42 |
| Vivasight 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. Video Double Lumen Tube (VDLT): Participant receives video double lumen tube (VDLT) placement before surgery. Under General Anesthesia, the Video Double Lumen Tube (VDLT) was inserted with conventional laryngoscopy or video laryngoscopy as per the preference of the anesthesiologist. Attending anesthesiologists performed all the intubations. Prior to insertion, the VDLT was connected to its accompanying external monitor via a mini universal serial bus port. | 38 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Mallinckrodt Double Lumen Tube (DLT) | Vivasight Video Double Lumen Tube (VDLT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 15 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 23 Participants | 43 Participants |
| American Society of Anesthesiologist (ASA) Status ASA I | 1 Participants | 0 Participants | 1 Participants |
| American Society of Anesthesiologist (ASA) Status ASA II | 7 Participants | 11 Participants | 18 Participants |
| American Society of Anesthesiologist (ASA) Status ASA III | 34 Participants | 25 Participants | 59 Participants |
| American Society of Anesthesiologist (ASA) Status ASA IV | 0 Participants | 2 Participants | 2 Participants |
| Mallampati Class I | 12 Participants | 5 Participants | 17 Participants |
| Mallampati Class II | 24 Participants | 25 Participants | 49 Participants |
| Mallampati Class III | 6 Participants | 6 Participants | 12 Participants |
| Mallampati Class IV | 0 Participants | 2 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 42 participants | 38 participants | 80 participants |
| Sex: Female, Male Female | 23 Participants | 10 Participants | 33 Participants |
| Sex: Female, Male Male | 19 Participants | 28 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 38 |
| other Total, other adverse events | 0 / 42 | 0 / 38 |
| serious Total, serious adverse events | 0 / 42 | 0 / 38 |
Outcome results
Primary
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.
Time frame: During surgery (from induction to extubation), an average of 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mallinckrodt Double Lumen Tube (DLT) | Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation | 42 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation | 5 Participants |
p-value: <0.0001t-test, 2 sided
Secondary
Dislodgement During Positioning and Surgery
Time frame: During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mallinckrodt Double Lumen Tube (DLT) | Dislodgement During Positioning and Surgery | Positioning | 9 Participants |
| Mallinckrodt Double Lumen Tube (DLT) | Dislodgement During Positioning and Surgery | Surgery | 3 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Dislodgement During Positioning and Surgery | Positioning | 8 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Dislodgement During Positioning and Surgery | Surgery | 5 Participants |
Secondary
Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mallinckrodt Double Lumen Tube (DLT) | Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff | 2 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff | 7 Participants |
p-value: 0.078t-test, 2 sided
Secondary
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.
Time frame: During surgery (from induction to extubation), an average of 1 hour
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mallinckrodt Double Lumen Tube (DLT) | Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System | Good view | 42 Participants |
| Mallinckrodt Double Lumen Tube (DLT) | Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System | Adequate view | 0 Participants |
| Mallinckrodt Double Lumen Tube (DLT) | Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System | Poor | 0 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System | Good view | 33 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System | Adequate view | 5 Participants |
| Vivasight Video Double Lumen Tube (VDLT) | Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System | Poor | 0 Participants |
p-value: 0.0209t-test, 2 sided