Trial Outcomes & Findings for Displacement Between PVC and Silicon DLT (NCT NCT02691468)
NCT ID: NCT02691468
Last Updated: 2021-08-10
Results Overview
The tracheal distance was defined as the distance between the distal tip of the tracheal lumen and tracheal carina whereas the bronchial distance was defined as that between the bronchial carina and distal tip of endobronchial lumen. The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively. Clinically significant displacement was defined when the DLT was deviated by more than 10 mm from the initial correct position, regardless of the direction of displacement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
from supine to lateral decubitus position during surgery
Results posted on
2021-08-10
Participant Flow
One hundred and eight adult patients, aged between 18 and 75 years, American Society of Anesthesiologists (ASA) physical status 1 \~ 3 scheduled for elective thoracic surgery were enrolled.
Patients with emergency surgery, difficult intubation, poor lung function to accomplish one-lung ventilation (OLV) during surgery were excluded.
Participant milestones
| Measure |
Polyvinyl Chloride (PVC) Double Lumen Tube (DLT)
After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.
PVC DLT: PVC DLT is type of double lumen tube that is composed of polyvinlyl chloride.
|
Silicon Double Lumen Tube (DLT)
After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.
silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Polyvinyl Chloride (PVC) Double Lumen Tube (DLT)
After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.
PVC DLT: PVC DLT is type of double lumen tube that is composed of polyvinlyl chloride.
|
Silicon Double Lumen Tube (DLT)
After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.
silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
|
|---|---|---|
|
Overall Study
Bronchial blocker use
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Failure to advance FOB
|
2
|
0
|
Baseline Characteristics
inclusion in final analysis
Baseline characteristics by cohort
| Measure |
PVC DLT
n=54 Participants
After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.
PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC
|
Silicon DLT
n=54 Participants
After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.
silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=54 Participants • inclusion in final analysis
|
0 Participants
n=54 Participants • inclusion in final analysis
|
1 Participants
n=108 Participants • inclusion in final analysis
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=54 Participants • inclusion in final analysis
|
47 Participants
n=54 Participants • inclusion in final analysis
|
67 Participants
n=108 Participants • inclusion in final analysis
|
|
Age, Categorical
>=65 years
|
33 Participants
n=54 Participants • inclusion in final analysis
|
7 Participants
n=54 Participants • inclusion in final analysis
|
40 Participants
n=108 Participants • inclusion in final analysis
|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 16.1 • n=54 Participants
|
57.8 years
STANDARD_DEVIATION 14.9 • n=54 Participants
|
57.3 years
STANDARD_DEVIATION 15.5 • n=108 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=54 Participants • inclusion in final analysis
|
18 Participants
n=54 Participants • inclusion in final analysis
|
36 Participants
n=108 Participants • inclusion in final analysis
|
|
Sex: Female, Male
Male
|
36 Participants
n=54 Participants • inclusion in final analysis
|
36 Participants
n=54 Participants • inclusion in final analysis
|
72 Participants
n=108 Participants • inclusion in final analysis
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: from supine to lateral decubitus position during surgeryThe tracheal distance was defined as the distance between the distal tip of the tracheal lumen and tracheal carina whereas the bronchial distance was defined as that between the bronchial carina and distal tip of endobronchial lumen. The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively. Clinically significant displacement was defined when the DLT was deviated by more than 10 mm from the initial correct position, regardless of the direction of displacement.
Outcome measures
| Measure |
PVC DLT
n=48 Participants
After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.
PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC
|
Silicon DLT
n=52 Participants
After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.
silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
|
|---|---|---|
|
the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: from supine to lateral decubitus positionThe displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively. The critical malposition was defined when the DLT was required repostion for successful OLV during position change
Outcome measures
| Measure |
PVC DLT
n=48 Participants
After the induction of general anesthesia, a left sided PVC DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of PVC DLT is calculated from difference in tracheal distance between supine and lateral position.
PVC DLT: PVC DLT is type of double lumen tube that is composed of PVC
|
Silicon DLT
n=52 Participants
After the induction of general anesthesia, a left sided silicon DLT was placed by the anesthesiologist using direct laryngoscopy. Tube position was confirmed with fiberotic bronchoscope.
The first set of measurements tracheal distance(from tracheal carina to proximal tip of DLT) and bronchial distance(from bronchial carina to distal tip of DLT) measured by bronchoscope is taken in supine position .
The second set of measurements is taken in lateral position after position change.
The displacement of silicon DLT is calculated from difference in tracheal distance between supine and lateral position.
silicon DLT: silicon DLT is type of double lumen tube that is composed of silicon
|
|---|---|---|
|
the Incidence of Critical Malposition of DLTs
|
4 participants
|
4 participants
|
Adverse Events
PVC DLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silicon DLT
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
Sung Mee Jung, M.D
Department of Anesthesiology and Pain medicine, Yeungnam University School of Medicine, Daegu, Republic of Korea
Phone: +82-53-620-3368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place