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: Completed
• Conditions: Postoperative Complications; Soft Tissue Injuries; Thoracic Surgery; Hoarseness; Sore Throat; Intubation, Intratracheal
• Intervention / Treatment: Procedure: Bronchoscope guided advancement; Procedure: Conventional advancement

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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).	Procedure: Bronchoscope guided advancement; 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.
Active Comparator: Conventional group; DLT is advanced blindly to the main bronchus level (Conventional advancement).	Procedure: Conventional advancement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative sore throat (24 h)	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	none/mild/severe	Intraoperative
Resistance against DLT advancement	none/mild/severe	Intraoperative
Intubation time	stop of initial mask ventilation - intubation through vocal cord	Intraoperative
The number of attempts for intubation	The number of attempts for intubation through vocal cord	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	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	Intraoperative
Heart rate	Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning	Intraoperative
Mean arterial pressure	Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning	Intraoperative
IV PCA	Fentanyl usage with PCA	At 24 hours after the extubation
Airway injury (Lt. main bronhcus, carina, trachea)	When spontaneous breathing of the patient starts after the thoracic surgery	Intraoperative
Airway injury (vocal cord)	When spontaneous breathing of the patient starts after the thoracic surgery	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	24 hours after tracheal extubation
Post-operative hoarseness (1 h)	The incidence of hoarseness after tracheal extubation	1 hour after tracheal extubation
Post-operative hoarseness (24 h)	The incidence of hoarseness after tracheal extubation	24 hour after tracheal extubation
Oral dryness	The incidence of oral dryness	24 hours after tracheal extubation
Dysphagia	The incidence of dysphagia	24 hours after tracheal extubation

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

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): January 15, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

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)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No