Trial Outcomes & Findings for Video Double-Lumen Tube Prospective Randomized Study (NCT NCT02429414)
NCT ID: NCT02429414
Last Updated: 2022-03-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
83 participants
Primary outcome timeframe
During surgery (from induction to extubation), an average of 1 hour
Results posted on
2022-03-29
Participant Flow
Recruitment Period: September 2015 - July 2016
83 participants consented, 3 were not eligible due to (1) withdrew consent, (1) withdrawal by subject, and (1) physician's decision.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
|
Overall Study
COMPLETED
|
42
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mallinckrodt Double Lumen Tube (DLT)
n=42 Participants
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.
|
Vivasight Video Double Lumen Tube (VDLT)
n=38 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=42 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=42 Participants
|
23 Participants
n=38 Participants
|
43 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=42 Participants
|
15 Participants
n=38 Participants
|
37 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=42 Participants
|
10 Participants
n=38 Participants
|
33 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=42 Participants
|
28 Participants
n=38 Participants
|
47 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
42 participants
n=42 Participants
|
38 participants
n=38 Participants
|
80 participants
n=80 Participants
|
|
American Society of Anesthesiologist (ASA) Status
ASA I
|
1 Participants
n=42 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=80 Participants
|
|
American Society of Anesthesiologist (ASA) Status
ASA II
|
7 Participants
n=42 Participants
|
11 Participants
n=38 Participants
|
18 Participants
n=80 Participants
|
|
American Society of Anesthesiologist (ASA) Status
ASA III
|
34 Participants
n=42 Participants
|
25 Participants
n=38 Participants
|
59 Participants
n=80 Participants
|
|
American Society of Anesthesiologist (ASA) Status
ASA IV
|
0 Participants
n=42 Participants
|
2 Participants
n=38 Participants
|
2 Participants
n=80 Participants
|
|
Mallampati
Class I
|
12 Participants
n=42 Participants
|
5 Participants
n=38 Participants
|
17 Participants
n=80 Participants
|
|
Mallampati
Class II
|
24 Participants
n=42 Participants
|
25 Participants
n=38 Participants
|
49 Participants
n=80 Participants
|
|
Mallampati
Class III
|
6 Participants
n=42 Participants
|
6 Participants
n=38 Participants
|
12 Participants
n=80 Participants
|
|
Mallampati
Class IV
|
0 Participants
n=42 Participants
|
2 Participants
n=38 Participants
|
2 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: During surgery (from induction to extubation), an average of 1 hourThe 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.
Outcome measures
| Measure |
Mallinckrodt Double Lumen Tube (DLT)
n=42 Participants
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.
|
Vivasight Video Double Lumen Tube (VDLT)
n=38 Participants
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.
|
|---|---|---|
|
Number of Participants With Fiberoptic Use During Surgeries Requiring Lung Isolation
|
42 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During surgery (from induction to extubation), an average of 1 hourGood 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.
Outcome measures
| Measure |
Mallinckrodt Double Lumen Tube (DLT)
n=42 Participants
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.
|
Vivasight Video Double Lumen Tube (VDLT)
n=38 Participants
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.
|
|---|---|---|
|
Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System
Good view
|
42 Participants
|
33 Participants
|
|
Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System
Adequate view
|
0 Participants
|
5 Participants
|
|
Quality of View Provided by the VDLT (Embedded Camera) vs. DLT (FOB) Using Grading System
Poor
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 DayOutcome measures
| Measure |
Mallinckrodt Double Lumen Tube (DLT)
n=42 Participants
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.
|
Vivasight Video Double Lumen Tube (VDLT)
n=38 Participants
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.
|
|---|---|---|
|
Number of Participants in Which Anesthesiologist Was Able to Forewarn/ Anticipate Dislodging of Endobronchial Cuff
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: During positioning, up to 30 minutes and during surgery (from induction to extubation), up to 1 hourOutcome measures
| Measure |
Mallinckrodt Double Lumen Tube (DLT)
n=14 Participants
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.
|
Vivasight Video Double Lumen Tube (VDLT)
n=13 Participants
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.
|
|---|---|---|
|
Dislodgement During Positioning and Surgery
Positioning
|
9 Participants
|
8 Participants
|
|
Dislodgement During Positioning and Surgery
Surgery
|
3 Participants
|
5 Participants
|
Adverse Events
Mallinckrodt Double Lumen Tube (DLT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vivasight Video Double Lumen Tube (VDLT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jagtar S Heir, Professor, Anesthesiology & PeriOper Med
UT MD Anderson Cancer Center
Phone: (713) 745-3793
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place