Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT02691468
Displacement Between PVC and Silicon DLT
A study testing PVC DLT and silicon DLT in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure and Surgical Procedure, Unspecified, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is to compare difference of displacement between Polyvinyl Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position from supine to lateral in thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure, Surgical Procedure, Unspecified
- What is being tested?
- PVC DLT and silicon DLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient required differential lung ventilation in elective thoracic surgery American society of Anesthesiologist physical status(ASA PS) 1~3
Who cannot join
- emergency surgery, difficult intubation, poor lung function to accomplish OLV during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Displacement Between Polyvinyl Chloride(PVC) and Silicon Double-Lumen Endobronchial Tubes(DLT) During Change of Position
The purpose of this study is to compare difference of displacement between Polyvinyl Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position from supine to lateral in thoracic surgery.
Read the detailed description
Lung isolation and differential lung ventilation, resulting in collapse of operative lung and ventilation of non-operating lung (one lung ventilation; OLV) are essential for thoracic surgery in lung, esophagus and thoracic aorta.
DLT, consisted of tracheal and bronchial lumens, is commonly used to perform differential lung ventilation. The correct position of each lumen in trachea and main bronchus is essential for successful OLV. However, DLT displacement occurs commonly while patients are changed position from the supine to the lateral. The deleterious consequences of a malpositioned DLT can be substantial, even life-threatening including severe hypoxemia.
Considering displacement of DLT during position change and surgical traction, previous studies recommended endobronchial cuff of DLT should be positioned at 0.5cm below the tracheal carina when using left-sided DLT. However, it is based on the data from several research conducted by PVC DLT.
These days, Silicon DLT, different in material from PVC DLT, is also widely used in clinical practice. Silicon DLT is different in not only position of ballon but also distance of each lumen. Furthermore,there are no identified studies about the displacement of silicon DLT during patient position change in thoracic surgery.
Therefore, it is necessary to measure the movement of silicon DLT during positional change from supine to lateral for finding the proper positioning of DLT.
The investigators compare the difference of displacement between PVC DLT and silicon DLT distance during positional change from supine to lateral by fiberotic bronchoscope. And the investigators try to find proper position of PVC and silicon DLT, respectively, to perform safe and successful OLV during thoracic surgery.
- Conditions
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure, Surgical Procedure, Unspecified
- Being tested
- PVC DLT, silicon DLT
- Keywords
- one lung ventilation, double lumen endobronchial tube, displacement, Fiberoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVC DLTDevice
Also called PVC double-lumen tube
PVC DLT is type of double lumen tube that is composed of PVC
silicon DLTDevice
Also called silicon double-lumen tube
silicon DLT is type of double lumen tube that is composed of silicon
| Study group | Role | What they receive |
|---|---|---|
| PVC DLT | Active comparator | 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. Receives: Device: PVC DLT |
| silicon DLT | Active comparator | 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. Receives: Device: silicon DLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position
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.
Measured: from supine to lateral decubitus position during surgery
Secondary outcomes (1)
the Incidence of Critical Malposition of DLTs
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. The critical malposition was defined when the DLT was required repostion for successful OLV during position change
Measured: from supine to lateral decubitus position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion1 Apr 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Tube Wrongly Placed During Anesthetic ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Mee Jung, Yeungnam University College of Medicine
- Investigators
- Sung Mee applejsm@gmail.com, MD, Principal investigator, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691468
- Sponsor's protocol ID
- YeungnamUDLT
- Status last verified
- Aug 2021
- First submitted
- 5 Feb 2016
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.
PubMed 3674473Desiderio DP, Burt M, Kolker AC, Fischer ME, Reinsel R, Wilson RS. The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):595-8. doi: 10.1016/s1053-0770(97)90011-2.
PubMed 9263092Yoon TG, Chang HW, Ryu HG, Kwon TD, Bahk JH. Use of a neck brace minimizes double-lumen tube displacement during patient positioning. Can J Anaesth. 2005 Apr;52(4):413-7. doi: 10.1007/BF03016286.
PubMed 15814758
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Displacement Between Polyvinyl Chloride(PVC) and Silicon Double-Lumen Endobronchial Tubes(DLT) During Change of Position
- ClinicalTrials.gov ID
- NCT02691468
- Acronym / sponsor ID
- YeungnamUDLT
- Conditions
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure, Surgical Procedure, Unspecified
- Keywords
- one lung ventilation, double lumen endobronchial tube, displacement, Fiberoptic bronchoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare difference of displacement between Polyvinyl Chloride(PVC) and Silicon double-lumen endobronchial tubes(DLTs) during changing position from supine to lateral in thoracic surgery.
Detailed description
Lung isolation and differential lung ventilation, resulting in collapse of operative lung and ventilation of non-operating lung (one lung ventilation; OLV) are essential for thoracic surgery in lung, esophagus and thoracic aorta.
DLT, consisted of tracheal and bronchial lumens, is commonly used to perform differential lung ventilation. The correct position of each lumen in trachea and main bronchus is essential for successful OLV. However, DLT displacement occurs commonly while patients are changed position from the supine to the lateral. The deleterious consequences of a malpositioned DLT can be substantial, even life-threatening including severe hypoxemia.
Considering displacement of DLT during position change and surgical traction, previous studies recommended endobronchial cuff of DLT should be positioned at 0.5cm below the tracheal carina when using left-sided DLT. However, it is based on the data from several research conducted by PVC DLT.
These days, Silicon DLT, different in material from PVC DLT, is also widely used in clinical practice. Silicon DLT is different in not only position of ballon but also distance of each lumen. Furthermore,there are no identified studies about the displacement of silicon DLT during patient position change in thoracic surgery.
Therefore, it is necessary to measure the movement of silicon DLT during positional change from supine to lateral for finding the proper positioning of DLT.
The investigators compare the difference of displacement between PVC DLT and silicon DLT distance during positional change from supine to lateral by fiberotic bronchoscope. And the investigators try to find proper position of PVC and silicon DLT, respectively, to perform safe and successful OLV during thoracic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVC DLT | Active comparator | Device: PVC DLTAfter 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. |
| silicon DLT | Active comparator | Device: silicon DLTAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient required differential lung ventilation in elective thoracic surgery American society of Anesthesiologist physical status(ASA PS) 1~3
Key exclusion criteria (1 listed)
- emergency surgery, difficult intubation, poor lung function to accomplish OLV during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVC DLTAlso: PVC double-lumen tubePVC DLT is type of double lumen tube that is composed of PVC | Device | PVC DLT |
| silicon DLTAlso: silicon double-lumen tubesilicon DLT is type of double lumen tube that is composed of silicon | Device | silicon DLT |
Primary outcome
the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position
Time frame: from supine to lateral decubitus position during surgery
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.
1 secondary outcome
the Incidence of Critical Malposition of DLTs
Time frame: from supine to lateral decubitus position
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3674473Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.
- Background: PubMed 9263092Desiderio DP, Burt M, Kolker AC, Fischer ME, Reinsel R, Wilson RS. The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning. J Cardiothorac Vasc Anesth. 1997 Aug;11(5):595-8. doi: 10.1016/s1053-0770(97)90011-2.
- Background: PubMed 15814758Yoon TG, Chang HW, Ryu HG, Kwon TD, Bahk JH. Use of a neck brace minimizes double-lumen tube displacement during patient positioning. Can J Anaesth. 2005 Apr;52(4):413-7. doi: 10.1007/BF03016286.
- Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology.Link provided by the sponsor.
- The effects of endobronchial cuff inflation on double-lumen endobronchial tube movement after lateral decubitus positioning.Link provided by the sponsor.
- Use of a neck brace minimizes double-lumen tube displacement during patient positioning.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Recruiting
Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing
Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Recruiting
Role of Point of Care Ultrasound in Endotracheal Tube Placement
Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Mee applejsm@gmail.com, MD principal investigator
Yeungnam University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVC DLT and silicon DLT in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure and Surgical Procedure, Unspecified, run by Yeungnam University College of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position (time frame: from supine to lateral decubitus position during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691468, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.