Intubation;DifficultNCT03392766
Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.
A study testing single lumen tube and bronchial blocker and double lumen tube in people with Intubation;Difficult and Thoracic Diseases, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Intubation;Difficult, Thoracic Diseases
- What is being tested?
- single lumen tube and bronchial blocker and double lumen tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Feb 2018to 22 Apr 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 requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2
Who cannot join
- abnormality of upper airway gastroesophageal disease risk of aspiration BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.
Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. 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 with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.
- Conditions
- Intubation;Difficult, Thoracic Diseases
- Being tested
- single lumen tube and bronchial blocker, double lumen tube
- Keywords
- fibreoptic intubation, double lumen tube, difficult intubation
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single lumen tube and bronchial blockerDevice
neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
double lumen tubeDevice
neck collar apply. fibreoptic intubation with double lumen tube.
| Study group | Role | What they receive |
|---|---|---|
| Single lumen tube and bronchial blocker | Experimental | neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker Receives: Device: single lumen tube and bronchial blocker |
| Double lumen tube | Experimental | neck collar apply. fibreoptic intubation with double lumen tube Receives: Device: double lumen tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.
Measured: through study completion, an average of 4 hour
Secondary outcomes (5)
insertion time
the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina
Measured: through study completion, an average of 4 hour
railroading time
the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina.
Measured: through study completion, an average of 4 hour
grade of ease of insertion over fibreoptic bronchoscope
1, no difficulty passing the tube; 2, obstruction while passing the tube, relieved by withdrawal and a 90° counter-clockwise rotation; 3, obstruction necessitating more than one manipulation or external laryngeal manipulation; 4, direct laryngoscopy was required.
Measured: through study completion, an average of 4 hour
trauma around the glottis
fibreoptic observation of the glottic bleeding.
Measured: through study completion, an average of 4 hour
complication at the post-anesthesia care unit
hoarseness, sore throat, swallowing difficulty
Measured: through study completion, an average of 4 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start9 Feb 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 80 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 unversity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392766
- Sponsor's protocol ID
- AJIRB-DEV-OBS-17-247
- Status last verified
- Apr 2019
- First submitted
- 2 Jan 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang S, Chae YJ, Kim DH, Bae SY, Yoo JY. Comparison of silicone double-lumen tube and polyvinyl chloride single-lumen tube in fiberoptic tracheal intubation on a difficult airway model: a randomized controlled non-inferiority trial. Sci Rep. 2023 May 24;13(1):8397. doi: 10.1038/s41598-023-35635-1.
PubMed 37225777
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.
- ClinicalTrials.gov ID
- NCT03392766
- Acronym / sponsor ID
- AJIRB-DEV-OBS-17-247
- Conditions
- Intubation;Difficult, Thoracic Diseases
- Keywords
- fibreoptic intubation, double lumen tube, difficult intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 8 Jan 2018 (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.
Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. 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 with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single lumen tube and bronchial blocker | Experimental | Device: single lumen tube and bronchial blockerneck collar apply. fibreoptic intubation with single lumen tube and brochial blocker |
| Double lumen tube | Experimental | Device: double lumen tubeneck collar apply. fibreoptic intubation with 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 requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2
Key exclusion criteria (1 listed)
- abnormality of upper airway gastroesophageal 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 |
|---|---|---|
| single lumen tube and bronchial blockerneck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker. | Device | Single lumen tube and bronchial blocker |
| double lumen tubeneck collar apply. fibreoptic intubation with double lumen tube. | Device | Double lumen tube |
Primary outcome
intubation time
Time frame: through study completion, an average of 4 hour
the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.
5 secondary outcomes
insertion time
Time frame: through study completion, an average of 4 hour
railroading time
Time frame: through study completion, an average of 4 hour
grade of ease of insertion over fibreoptic bronchoscope
Time frame: through study completion, an average of 4 hour
trauma around the glottis
Time frame: through study completion, an average of 4 hour
complication at the post-anesthesia care unit
Time frame: through study completion, an average of 4 hour
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 23 Apr 2019.
- Derived from this study: PubMed 37225777Kang S, Chae YJ, Kim DH, Bae SY, Yoo JY. Comparison of silicone double-lumen tube and polyvinyl chloride single-lumen tube in fiberoptic tracheal intubation on a difficult airway model: a randomized controlled non-inferiority trial. Sci Rep. 2023 May 24;13(1):8397. doi: 10.1038/s41598-023-35635-1.
- 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 unversity hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single lumen tube and bronchial blocker and double lumen tube in people with Intubation;Difficult and Thoracic Diseases, 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 23 Apr 2019. 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?
intubation time (time frame: through study completion, an average of 4 hour). 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 NCT03392766, which also lists 1 linked publication.
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 23 Apr 2019.