Intubation, IntratrachealNCT03368599
Endobronchial Intubation of Double-lumen Tube: Conventional Method vs Fiberoptic Bronchoscope Guide Method
A study testing Bronchoscope guided advancement and Conventional advancement in people with Intubation, Intratracheal and Postoperative Complications, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT intubation than with single one. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Intubation, Intratracheal, Postoperative Complications, Sore Throat
- What is being tested?
- Bronchoscope guided advancement and Conventional advancement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) class I - III
- Elective thoracic surgery
- Left-sided DLT intubation for one-lung ventilation
Who cannot join
- Female, height < 160 cm
- Pre-existing sore throat, hoarseness or airway injury
- Duration of surgery > 6 h
- Upper respiratory tract infection
- Cervical spine diseases
- Presence of tracheostomy
Show all 15Show fewer
- Pharyngeal neoplasm or abscess which can induce mechanical airway obstruction
- Mallampati score 4
- Obesity (BMI ≥ 35 kg/m2)
- Obstructive sleep apnea (OSA)
- Craniofacial anomaly
- Cormack grade 3b or 4
- History or high risk of difficult intubation / difficult mask ventilation
- Patients whom the direct laryngoscopy cannot be used for, because of weak teeth or small mouth opening
- Patients who refuse to participate in the study or from whom receive informed consent cannot be received.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: The Effect of Endobronchial Intubation of Double-lumen Tube on Post-operative Sore Throat, Hoarseness and Airway Injuries: A Comparison Between Conventional and Fiberoptic Bronchoscope-guided Intubation
Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT intubation than with single one. Which is may because DLT is relatively thicker, harder, sideway curved and therefore more likely to damage the vocal cord or trachea during intubation, and advanced deeper to the carina and main bronchus level. In the conventional method of intubation, DLT is rotated 90 degrees and advanced blindly to the main bronchus level after DLT is intubated through vocal cord using the direct laryngoscopy. After the blind advancement, the sufficient tube position needs to be gained and confirmed with the fiberoptic bronchoscope. In the bronchoscope guide method, after DLT is intubated through vocal cord using the direct laryngoscopy, the pathway into the targeted main bronchus is secured using the fiberoptic bronchoscope which is passed through a bronchial lumen of DLT. And then DLT can be advanced through the guide of the bronchoscope. In this study, we intend to compare post-operative sore throat, hoarseness and airway injury between the two methods. We hypothesize that the bronchoscope guide method can reduce the post-operative complications and airway injury because surrounding tissues of the airway can be less irritated by DLT intubation in the guide method than in a conventional.
For a constant guide effect, we use fiberoptic bronchoscopes with same outer diameter (4.1 mm) which can pass through a bronchial lumen of 37 and 39 Fr Lt. DLT and cannot pass through 35 Fr or smaller Lt. DLTs.
Read more
<Lt. DLT size selection>
- male: ≥160 cm, 39 French; < 160 cm, 37 French
- female: ≥160 cm, 37 French; < 160 cm, contraindication
- Conditions
- Intubation, Intratracheal, Postoperative Complications, Sore Throat, Hoarseness, Soft Tissue Injuries, Thoracic Surgery
- Being tested
- Bronchoscope guided advancement, Conventional advancement
- Medical subject headings
- Postoperative Complications, Pharyngitis, Hoarseness, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscope guided advancementProcedure or surgery
During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the bronchoscope-guided method. The method is as follows.
- Lt. DLT is intubated through vocal cord using the direct laryngoscopy.
- Pass the fiberoptic bronschoscope through a bronchial lumen of Lt. DLT.
- Secure the pathway into the Lt. main bronchus by advancing the bronchoscope into the Lt. main bronchus.
- Lt. DLT can be advanced through the guide of the bronchoscope into Lt. main bronchus.
- After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified.
Conventional advancementProcedure or surgery
During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the conventional method. The method is as follows.
- Lt. DLT is intubated through vocal cord using the direct laryngoscopy.
- Rotate Lt. DLT 90 degrees to the left side.
- Advance Lt. DLT blindly to main bronchus level.
- After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscope guide group | Experimental | DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement). Receives: Procedure: Bronchoscope guided advancement |
| Conventional group | Active comparator | DLT is advanced blindly to the main bronchus level (Conventional advancement). Receives: Procedure: Conventional advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sore throat (24 h)
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most
Measured: 24 hour after tracheal extubation
Secondary outcomes (16)
Resistance against DLT passage through vocal cord
none/mild/severe
Measured: Intraoperative
Resistance against DLT advancement
none/mild/severe
Measured: Intraoperative
Intubation time
stop of initial mask ventilation - intubation through vocal cord
Measured: Intraoperative
The number of attempts for intubation
The number of attempts for intubation through vocal cord
Measured: Intraoperative
The number of right misplacement of Lt. DLT
The number of right misplacement of Lt. DLT confirmed using the fiberoptic bronchoscope after the advancement
Measured: Intraoperative
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus
Measured: Intraoperative
Heart rate
Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Measured: Intraoperative
Mean arterial pressure
Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Measured: Intraoperative
IV PCA
Fentanyl usage with PCA
Measured: At 24 hours after the extubation
Airway injury (Lt. main bronhcus, carina, trachea)
When spontaneous breathing of the patient starts after the thoracic surgery
Measured: Intraoperative
Airway injury (vocal cord)
When spontaneous breathing of the patient starts after the thoracic surgery
Measured: Intraoperative
Post-operative sore throat (1 h)
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
Measured: 24 hours after tracheal extubation
Post-operative hoarseness (1 h)
The incidence of hoarseness after tracheal extubation
Measured: 1 hour after tracheal extubation
Post-operative hoarseness (24 h)
The incidence of hoarseness after tracheal extubation
Measured: 24 hour after tracheal extubation
Oral dryness
The incidence of oral dryness
Measured: 24 hours after tracheal extubation
Dysphagia
The incidence of dysphagia
Measured: 24 hours after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start15 Jan 2018
- Primary completion30 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Woo Park, Seoul National University Bundang Hospital
- Investigators
- Jin-Woo Park, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368599
- Sponsor's protocol ID
- B-1711-432-005
- Status last verified
- Sep 2019
- First submitted
- 1 Dec 2017
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
PubMed 7880666McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. doi: 10.1046/j.1365-2044.1999.00780.x.
PubMed 10995141Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7.
PubMed 26149601Park SH, Han SH, Do SH, Kim JW, Rhee KY, Kim JH. Prophylactic dexamethasone decreases the incidence of sore throat and hoarseness after tracheal extubation with a double-lumen endobronchial tube. Anesth Analg. 2008 Dec;107(6):1814-8. doi: 10.1213/ane.0b013e318185d093.
PubMed 19020122Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
PubMed 26787799Cheong KF, Koh KF. Placement of left-sided double-lumen endobronchial tubes: comparison of clinical and fibreoptic-guided placement. Br J Anaesth. 1999 Jun;82(6):920-1. doi: 10.1093/bja/82.6.920.
PubMed 10562789Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. doi: 10.1097/00000542-200609000-00009.
PubMed 16931978Park JW, Jo JH, Park JH, Bae YK, Park SJ, Cho SW, Han SH, Kim JH. Comparison of conventional and fibreoptic-guided advance of left-sided double-lumen tube during endobronchial intubation: A randomised controlled trial. Eur J Anaesthesiol. 2020 Jun;37(6):466-473. doi: 10.1097/EJA.0000000000001216.
PubMed 32332265
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endobronchial Intubation of Double-lumen Tube on Post-operative Sore Throat, Hoarseness and Airway Injuries: A Comparison Between Conventional and Fiberoptic Bronchoscope-guided Intubation
- ClinicalTrials.gov ID
- NCT03368599
- Acronym / sponsor ID
- B-1711-432-005
- Conditions
- Intubation, Intratracheal, Postoperative Complications, Sore Throat, Hoarseness, Soft Tissue Injuries, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 11 Dec 2017 (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.
Double lumen tube (DLT) needs to be intubated to isolate ventilations of left and right lungs for thoracic surgery. Post-operative sore throat and hoarseness are more frequent with DLT intubation than with single one. Which is may because DLT is relatively thicker, harder, sideway curved and therefore more likely to damage the vocal cord or trachea during intubation, and advanced deeper to the carina and main bronchus level. In the conventional method of intubation, DLT is rotated 90 degrees and advanced blindly to the main bronchus level after DLT is intubated through vocal cord using the direct laryngoscopy. After the blind advancement, the sufficient tube position needs to be gained and confirmed with the fiberoptic bronchoscope. In the bronchoscope guide method, after DLT is intubated through vocal cord using the direct laryngoscopy, the pathway into the targeted main bronchus is secured using the fiberoptic bronchoscope which is passed through a bronchial lumen of DLT. And then DLT can be advanced through the guide of the bronchoscope. In this study, we intend to compare post-operative sore throat, hoarseness and airway injury between the two methods. We hypothesize that the bronchoscope guide method can reduce the post-operative complications and airway injury because surrounding tissues of the airway can be less irritated by DLT intubation in the guide method than in a conventional.
For a constant guide effect, we use fiberoptic bronchoscopes with same outer diameter (4.1 mm) which can pass through a bronchial lumen of 37 and 39 Fr Lt. DLT and cannot pass through 35 Fr or smaller Lt. DLTs.
<Lt. DLT size selection>
- male: ≥160 cm, 39 French; < 160 cm, 37 French
- female: ≥160 cm, 37 French; < 160 cm, contraindication
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchoscope guide group | Experimental | Procedure: Bronchoscope guided advancementDLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement). |
| Conventional group | Active comparator | Procedure: Conventional advancementDLT is advanced blindly to the main bronchus level (Conventional advancement). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) class I - III
- Elective thoracic surgery
- Left-sided DLT intubation for one-lung ventilation
Key exclusion criteria (15 listed)
- Female, height < 160 cm
- Pre-existing sore throat, hoarseness or airway injury
- Duration of surgery > 6 h
- Upper respiratory tract infection
- Cervical spine diseases
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 |
|---|---|---|
| Bronchoscope guided advancementDuring the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the bronchoscope-guided method. The method is as follows. 1. Lt. DLT is intubated through vocal cord using the direct laryngoscopy. 2. Pass the fiberoptic bronschoscope through a bronchial lumen of Lt. DLT. 3. Secure the pathway into the Lt. main bronchus by advancing the bronchoscope into the Lt. main bronchus. 4. Lt. DLT can be advanced through the guide of the bronchoscope into Lt. main bronchus. 5. After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified. | Procedure or surgery | Bronchoscope guide group |
| Conventional advancementDuring the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the conventional method. The method is as follows. 1. Lt. DLT is intubated through vocal cord using the direct laryngoscopy. 2. Rotate Lt. DLT 90 degrees to the left side. 3. Advance Lt. DLT blindly to main bronchus level. 4. After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified. | Procedure or surgery | Conventional group |
Primary outcome
Post-operative sore throat (24 h)
Time frame: 24 hour after tracheal extubation
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most
16 secondary outcomes
Resistance against DLT passage through vocal cord
Time frame: Intraoperative
Resistance against DLT advancement
Time frame: Intraoperative
Intubation time
Time frame: Intraoperative
The number of attempts for intubation
Time frame: Intraoperative
The number of right misplacement of Lt. DLT
Time frame: Intraoperative
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning
Time frame: Intraoperative
Heart rate
Time frame: Intraoperative
Mean arterial pressure
Time frame: Intraoperative
IV PCA
Time frame: At 24 hours after the extubation
Airway injury (Lt. main bronhcus, carina, trachea)
Time frame: Intraoperative
Airway injury (vocal cord)
Time frame: Intraoperative
Post-operative sore throat (1 h)
Time frame: 24 hours after tracheal extubation
Post-operative hoarseness (1 h)
Time frame: 1 hour after tracheal extubation
Post-operative hoarseness (24 h)
Time frame: 24 hour after tracheal extubation
Oral dryness
Time frame: 24 hours after tracheal extubation
Dysphagia
Time frame: 24 hours after tracheal extubation
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 10 Sep 2019.
- Background: PubMed 7880666Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
- Background: PubMed 10995141McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. doi: 10.1046/j.1365-2044.1999.00780.x.
- Background: PubMed 26149601Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7.
- Background: PubMed 19020122Park SH, Han SH, Do SH, Kim JW, Rhee KY, Kim JH. Prophylactic dexamethasone decreases the incidence of sore throat and hoarseness after tracheal extubation with a double-lumen endobronchial tube. Anesth Analg. 2008 Dec;107(6):1814-8. doi: 10.1213/ane.0b013e318185d093.
- Results publication: PubMed 26787799Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
- Results publication: PubMed 10562789Cheong KF, Koh KF. Placement of left-sided double-lumen endobronchial tubes: comparison of clinical and fibreoptic-guided placement. Br J Anaesth. 1999 Jun;82(6):920-1. doi: 10.1093/bja/82.6.920.
- Results publication: PubMed 16931978Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. doi: 10.1097/00000542-200609000-00009.
- Derived from this study: PubMed 32332265Park JW, Jo JH, Park JH, Bae YK, Park SJ, Cho SW, Han SH, Kim JH. Comparison of conventional and fibreoptic-guided advance of left-sided double-lumen tube during endobronchial intubation: A randomised controlled trial. Eur J Anaesthesiol. 2020 Jun;37(6):466-473. doi: 10.1097/EJA.0000000000001216.
- 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.
Jin-Woo Park, MD principal investigator
Seoul National University Bundang 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 Bronchoscope guided advancement and Conventional advancement in people with Intubation, Intratracheal and Postoperative Complications, run by Seoul National University Bundang Hospital 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 15 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 Sep 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?
Post-operative sore throat (24 h) (time frame: 24 hour after tracheal extubation). 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 NCT03368599, which also lists 8 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 Sep 2019.