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

• ClinicalTrials.gov Identifier: NCT03368599
• Recruitment Status: Completed
• First Posted: December 11, 2017
• Last Update Posted: September 10, 2019
• Sponsor: Seoul National University Bundang Hospital
• Information provided by (Responsible Party): Jin-Woo Park, Seoul National University Bundang Hospital

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Intubation, Intratracheal; Postoperative Complications; Sore Throat; Hoarseness; Soft Tissue Injuries; Thoracic Surgery	Procedure: Bronchoscope guided advancement; Procedure: Conventional advancement	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 15, 2018
• Actual Primary Completion Date: January 30, 2019
• Actual Study Completion Date: January 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Resistance against DLT passage through vocal cord [ Time Frame: Intraoperative ]
   none/mild/severe
2. Resistance against DLT advancement [ Time Frame: Intraoperative ]
   none/mild/severe
3. Intubation time [ Time Frame: Intraoperative ]
   stop of initial mask ventilation - intubation through vocal cord
4. The number of attempts for intubation [ Time Frame: Intraoperative ]
   The number of attempts for intubation through vocal cord
5. 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
6. 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
7. Heart rate [ Time Frame: Intraoperative ]
   Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
8. Mean arterial pressure [ Time Frame: Intraoperative ]
   Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
9. IV PCA [ Time Frame: At 24 hours after the extubation ]
   Fentanyl usage with PCA
10. Airway injury (Lt. main bronhcus, carina, trachea) [ Time Frame: Intraoperative ]
    When spontaneous breathing of the patient starts after the thoracic surgery
11. Airway injury (vocal cord) [ Time Frame: Intraoperative ]
    When spontaneous breathing of the patient starts after the thoracic surgery
12. 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
13. Post-operative hoarseness (1 h) [ Time Frame: 1 hour after tracheal extubation ]
    The incidence of hoarseness after tracheal extubation
14. Post-operative hoarseness (24 h) [ Time Frame: 24 hour after tracheal extubation ]
    The incidence of hoarseness after tracheal extubation
15. Oral dryness [ Time Frame: 24 hours after tracheal extubation ]
    The incidence of oral dryness
16. Dysphagia [ Time Frame: 24 hours after tracheal extubation ]
    The incidence of dysphagia

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

• Principal Investigator: Jin-Woo Park, MD; Seoul National University Bundang Hospital

More Information

Publications of Results:

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.

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.

Other 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.

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jin-Woo Park, Assistant Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT03368599
• Other Study ID Numbers: B-1711-432-005
• First Posted: December 11, 2017
• Last Update Posted: September 10, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pharyngitis; Hoarseness; Dysphonia; Postoperative Complications; Soft Tissue Injuries; Pathologic Processes; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Voice Disorders; Laryngeal Diseases; Respiration Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms, Respiratory