Intubation;DifficultNCT03889847
Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
A study testing Fibreoptic intubation with silicone double lumen tube and Fibreoptic intubation with PVC double lumen tube in people with Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Fibreoptic intubation with silicone double lumen tube and Fibreoptic intubation with PVC double lumen tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2
Who cannot join
- abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube.
In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.
- Conditions
- Intubation;Difficult
- Being tested
- Fibreoptic intubation with silicone double lumen tube, Fibreoptic intubation with PVC double lumen tube
- Keywords
- Fiberoptic intubation, double lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibreoptic intubation with silicone double lumen tubeDevice
Fibreoptic intubation with silicone double lumen tube
Fibreoptic intubation with PVC double lumen tubeDevice
Fibreoptic intubation with PVC double lumen tube
| Study group | Role | What they receive |
|---|---|---|
| silicone DLT | Experimental | Fibreoptic intubation with silicone double lumen tube Receives: Device: Fibreoptic intubation with silicone double lumen tube |
| PVC DLT | Experimental | Fibreoptic intubation with PVC double lumen tube Receives: Device: Fibreoptic intubation with PVC double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
railroading grade
grade of ease of railroading over fibreoptic bronchoscope.
- no difficulty passing the tube
- obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2)
- obstruction necessitating more than one manipulation or external laryngeal manipulation
- direct laryngoscope was required
Measured: an average of 2 minutes
Secondary outcomes (4)
insertion time
time from insertion of FOB into mouth to tube placement into trachea and left main bronchus
Measured: an average of 2 minutes
number of patients with trauma around glottis, observed by FOB
glottic trauma observation through FOB outside the tube
Measured: an average of 2minutes
number of patients with tube repositioning during the surgery
count of tube repositioning with FOB during the surgery
Measured: an average of 3.5 hours
number of patients with complication of hoarseness, sore throat, and swallowing difficulty
hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit
Measured: an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start25 Apr 2019
- Primary completion19 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAE HEE KIM, Ajou University School of Medicine
- Investigators
- Dae Hee Kim, M.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889847
- Sponsor's protocol ID
- AJIRB-DEV-THE-18-44-
- Status last verified
- Jan 2021
- First submitted
- 18 Mar 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.
- ClinicalTrials.gov ID
- NCT03889847
- Acronym / sponsor ID
- AJIRB-DEV-THE-18-44-
- Conditions
- Intubation;Difficult
- Keywords
- Fiberoptic intubation, double lumen tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB easier than the Shilly tube.
In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silicone DLT | Experimental | Device: Fibreoptic intubation with silicone double lumen tubeFibreoptic intubation with silicone double lumen tube |
| PVC DLT | Experimental | Device: Fibreoptic intubation with PVC double lumen tubeFibreoptic intubation with PVC double lumen tube |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2
Key exclusion criteria (1 listed)
- abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI > 35
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 |
|---|---|---|
| Fibreoptic intubation with silicone double lumen tubeFibreoptic intubation with silicone double lumen tube | Device | silicone DLT |
| Fibreoptic intubation with PVC double lumen tubeFibreoptic intubation with PVC double lumen tube | Device | PVC DLT |
Primary outcome
railroading grade
Time frame: an average of 2 minutes
grade of ease of railroading over fibreoptic bronchoscope. 1. no difficulty passing the tube 2. obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2) 3. obstruction necessitating more than one manipulation or external laryngeal manipulation 4. direct laryngoscope was required
4 secondary outcomes
insertion time
Time frame: an average of 2 minutes
number of patients with trauma around glottis, observed by FOB
Time frame: an average of 2minutes
number of patients with tube repositioning during the surgery
Time frame: an average of 3.5 hours
number of patients with complication of hoarseness, sore throat, and swallowing difficulty
Time frame: an average of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Dae Hee Kim, M.D. principal investigator
Ajou University School 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 Fibreoptic intubation with silicone double lumen tube and Fibreoptic intubation with PVC double lumen tube in people with Intubation;Difficult, run by Ajou University School 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 20 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
railroading grade (time frame: an average of 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.