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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01551 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| E.T. View Medical Ltd | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Video Double Lumen Tube (DLT) | Device | Participant receives non-video double lumen tube (DLT) placement before surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During surgery (from induction to extubation), an average of 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jagtar S. Heir, DO | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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83 participants consented, 3 were not eligible due to (1) withdrew consent, (1) withdrawal by subject, and (1) physician's decision.
Recruitment Period: September 2015 - July 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | During surgery (from induction to extubation), an average of 1 hour |
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During surgery (from induction to extubation)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jagtar S Heir, Professor, Anesthesiology & PeriOper Med | UT MD Anderson Cancer Center | (713) 745-3793 | jsheir@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2016 | Dec 17, 2021 | Prot_SAP_000.pdf |
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| Fiberoptic Bronchoscopy (FOB) | Procedure | Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT. |
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| Video Double Lumen Tube (VDLT) | Device | Participant receives video double lumen tube (VDLT) placement before surgery. |
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| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| American Society of Anesthesiologist (ASA) Status | The ASA (American Society of Anesthesiology) score is a metric to determine if someone is healthy enough to tolerate surgery and anesthesia. ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
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| Mallampati | Class 1-complete visualization of the soft palate, Class II-complete visualization of the uvula, Class III- visualization of only the base of the uvula, and Class IV- soft palate is not visible at all. | Count of Participants | Participants |
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| OG001 | 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. |
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| 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. | Posted | Count of Participants | Participants | During surgery (from induction to extubation), an average of 1 hour |
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| Secondary | Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff | Posted | Count of Participants | Participants | 1 Day |
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| Secondary | Dislodgement During Positioning and Surgery | Posted | Count of Participants | Participants | During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hour |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. | 0 | 38 | 0 | 38 | 0 | 38 |
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| Poor |
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