Endobronchial Intubation of Double-lumen Tube: Conventional Method vs Fiberoptic Bronchoscope Guide Method

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368599
• Other study ID #: B-1711-432-005
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2019
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 31, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Intubation, Intratracheal
• Pharyngitis
• Postoperative Complications
• Soft Tissue Injuries
• Sore Throat
• Thoracic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. — View Citation

Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. — View Citation

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. Anesthesi — View Citation

McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. Review. — View Citation

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. — View Citation

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 — View Citation

Outcome

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