- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368599
Endobronchial Intubation of Double-lumen Tube: Conventional Method vs Fiberoptic Bronchoscope Guide Method
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.
<Lt. DLT size selection>
- male: ≥160 cm, 39 French; < 160 cm, 37 French
- female: ≥160 cm, 37 French; < 160 cm, contraindication
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA (American Society of Anesthesiologists) class I - III
- Elective thoracic surgery
- Left-sided DLT intubation for one-lung ventilation
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bronchoscope guide group
DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement).
|
During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the bronchoscope-guided method. The method is as follows.
|
Active Comparator: Conventional group
DLT is advanced blindly to the main bronchus level (Conventional advancement).
|
During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the conventional method. The method is as follows.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hour after tracheal extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resistance against DLT passage through vocal cord
Time Frame: Intraoperative
|
none/mild/severe
|
Intraoperative
|
Resistance against DLT advancement
Time Frame: Intraoperative
|
none/mild/severe
|
Intraoperative
|
Intubation time
Time Frame: Intraoperative
|
stop of initial mask ventilation - intubation through vocal cord
|
Intraoperative
|
The number of attempts for intubation
Time Frame: Intraoperative
|
The number of attempts for intubation through vocal cord
|
Intraoperative
|
The number of right misplacement of Lt. DLT
Time Frame: Intraoperative
|
The number of right misplacement of Lt. DLT confirmed using the fiberoptic bronchoscope after the advancement
|
Intraoperative
|
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning
Time Frame: Intraoperative
|
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus
|
Intraoperative
|
Heart rate
Time Frame: Intraoperative
|
Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
|
Intraoperative
|
Mean arterial pressure
Time Frame: Intraoperative
|
Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
|
Intraoperative
|
IV PCA
Time Frame: At 24 hours after the extubation
|
Fentanyl usage with PCA
|
At 24 hours after the extubation
|
Airway injury (Lt. main bronhcus, carina, trachea)
Time Frame: Intraoperative
|
When spontaneous breathing of the patient starts after the thoracic surgery
|
Intraoperative
|
Airway injury (vocal cord)
Time Frame: Intraoperative
|
When spontaneous breathing of the patient starts after the thoracic surgery
|
Intraoperative
|
Post-operative sore throat (1 h)
Time Frame: 24 hours after tracheal extubation
|
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
|
24 hours after tracheal extubation
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Post-operative hoarseness (1 h)
Time Frame: 1 hour after tracheal extubation
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The incidence of hoarseness after tracheal extubation
|
1 hour after tracheal extubation
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Post-operative hoarseness (24 h)
Time Frame: 24 hour after tracheal extubation
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The incidence of hoarseness after tracheal extubation
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24 hour after tracheal extubation
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Oral dryness
Time Frame: 24 hours after tracheal extubation
|
The incidence of oral dryness
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24 hours after tracheal extubation
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Dysphagia
Time Frame: 24 hours after tracheal extubation
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The incidence of dysphagia
|
24 hours after tracheal extubation
|
Collaborators and Investigators
Publications and helpful links
General 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.
- McHardy 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.
- Chang 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.
- Park 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.
- Seo 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.
- Cheong 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.
- Knoll 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.
- Park 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Neurologic Manifestations
- Wounds and Injuries
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Signs and Symptoms, Respiratory
- Laryngeal Diseases
- Voice Disorders
- Soft Tissue Injuries
- Postoperative Complications
- Pharyngitis
- Dysphonia
- Hoarseness
Other Study ID Numbers
- B-1711-432-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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