Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)NCT03782090
Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation
A study testing Endobronchial intubation in people with Intubation Tube(Intubation Using Double Lumen Endobronchial Tube), run by Yonsei University at 1 site in South Korea.
Trial summary
The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)
- What is being tested?
- Endobronchial intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2018to 31 Jan 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA classification 1-3
- aged between 20 to 85
- undergoing one lung ventilation using left-sided double-lumen endobronchial tube for thoracic surgery
Who cannot join
- Expected difficult intubation (neck extension<35 degrees, mandibular-hyoid distance < 6 cm, sternomental distance < 12.5 cm)
- anomaly of tracheobronchial tree
- intraluminal lesion in left or right bronchus
- Obesity (Body Mass Index > 30)
- upper respiratory infection
- Thoracic surgical history
- blood coagulation disorder
- emergency operation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance
Seoul, 03722
About this study
The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. The size of endobronchial tube is decided based on the diameter of left main bronchus measured on the CT finding of patients. After induction of general anesthesia, in patients assigned to control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after the tube is rotated 90º toward the left. The tube is advanced until slight resistance is felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not in optimal position, the depth of tube is corrected to optimal position under guidance of fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before extubation. The success of endobronchial intubation, position of endobronchial tube, the corrected depth of endobronchial tube, time consumption for endobronchial intubation and complication of intubation such as airway injury, pain, and hoarseness are compared between two groups.
- Being tested
- Endobronchial intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial intubationDevice
- In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube(Shiley®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. The tube is advanced according to the depth(cm) of the tube calculated by the height of patient(12.5+0.1*height). Afterwards, the depth of the tube is adjusted by the compliance of both lung.
- In experimental group, patients are intubated with novel double-lumen endobronchial tube(Ankor®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. Once the carinal cuff of the tube is passed through the vocal cord of patients, the carinal cuff is inflated with 5-8ml of air. The tube is advanced until the tube stops itself at some point along the tracheobronchial tree. And then the carinal cuff is deflated.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Endobronchial intubation using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA) Receives: Device: Endobronchial intubation |
| Experimental | Experimental | Endobronchial intubation using novel left-sided double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea) Receives: Device: Endobronchial intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal position of double-lumen endobronchial tube
On fiberoptic bronchoscopic view after intubation, optimal position of double-lumen endobronchial tube is defined when the bronchial cuff of the tube is immediately below the tracheal carina and there is a clear view of the left subcarina with unobstructed left upper and lower bronchi.
Measured: 1 day (after intubation)
Secondary outcomes (1)
The corrected depth of endobronchial tube
The corrected depth of endobronchial tube is defined as the difference between the depth of endobronchial tube before and after the depth of tube is corrected to optimal position under guidance of fiberoptic.
Measured: 1 day (after intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start5 Sep 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endotracheal tube (Ankor®,Insung Medical, Wonjou, S. Korea).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782090
- Sponsor's protocol ID
- 4-2018-0698
- Status last verified
- May 2019
- First submitted
- 18 Dec 2018
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation
- ClinicalTrials.gov ID
- NCT03782090
- Acronym / sponsor ID
- 4-2018-0698
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 20 Dec 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.
The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. The size of endobronchial tube is decided based on the diameter of left main bronchus measured on the CT finding of patients. After induction of general anesthesia, in patients assigned to control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after the tube is rotated 90º toward the left. The tube is advanced until slight resistance is felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not in optimal position, the depth of tube is corrected to optimal position under guidance of fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before extubation. The success of endobronchial intubation, position of endobronchial tube, the corrected depth of endobronchial tube, time consumption for endobronchial intubation and complication of intubation such as airway injury, pain, and hoarseness are compared between two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endotracheal tube (Ankor®,Insung Medical, Wonjou, S. Korea).
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Endobronchial intubationEndobronchial intubation using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA) |
| Experimental | Experimental | Device: Endobronchial intubationEndobronchial intubation using novel left-sided double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA classification 1-3
- aged between 20 to 85
- undergoing one lung ventilation using left-sided double-lumen endobronchial tube for thoracic surgery
Key exclusion criteria (8 listed)
- Expected difficult intubation (neck extension<35 degrees, mandibular-hyoid distance < 6 cm, sternomental distance < 12.5 cm)
- anomaly of tracheobronchial tree
- intraluminal lesion in left or right bronchus
- Obesity (Body Mass Index > 30)
- upper respiratory infection
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 |
|---|---|---|
| Endobronchial intubation1. In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube(Shiley®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. The tube is advanced according to the depth(cm) of the tube calculated by the height of patient(12.5+0.1*height). Afterwards, the depth of the tube is adjusted by the compliance of both lung. 2. In experimental group, patients are intubated with novel double-lumen endobronchial tube(Ankor®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. Once the carinal cuff of the tube is passed through the vocal cord of patients, the carinal cuff is inflated with 5-8ml of air. The tube is advanced until the tube stops itself at some point along the tracheobronchial tree. And then the carinal cuff is deflated. | Device | Control, Experimental |
Primary outcome
Optimal position of double-lumen endobronchial tube
Time frame: 1 day (after intubation)
On fiberoptic bronchoscopic view after intubation, optimal position of double-lumen endobronchial tube is defined when the bronchial cuff of the tube is immediately below the tracheal carina and there is a clear view of the left subcarina with unobstructed left upper and lower bronchi.
1 secondary outcome
The corrected depth of endobronchial tube
Time frame: 1 day (after intubation)
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 May 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial intubation in people with Intubation Tube(Intubation Using Double Lumen Endobronchial Tube), run by Yonsei University 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 3 inclusion and 8 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 May 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?
Optimal position of double-lumen endobronchial tube (time frame: 1 day (after intubation)). 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 May 2019.