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

Primary Purpose

Intubation, Intratracheal, Postoperative Complications, Sore Throat

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bronchoscope guided advancement
Conventional advancement
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intubation, Intratracheal

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bronchoscope guide group

Conventional group

Arm Description

DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement).

DLT is advanced blindly to the main bronchus level (Conventional advancement).

Outcomes

Primary Outcome Measures

Post-operative sore throat (24 h)
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most

Secondary Outcome Measures

Resistance against DLT passage through vocal cord
none/mild/severe
Resistance against DLT advancement
none/mild/severe
Intubation time
stop of initial mask ventilation - intubation through vocal cord
The number of attempts for intubation
The number of attempts for intubation through vocal cord
The number of right misplacement of Lt. DLT
The number of right misplacement of Lt. DLT confirmed using the fiberoptic bronchoscope after the advancement
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
Heart rate
Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Mean arterial pressure
Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
IV PCA
Fentanyl usage with PCA
Airway injury (Lt. main bronhcus, carina, trachea)
When spontaneous breathing of the patient starts after the thoracic surgery
Airway injury (vocal cord)
When spontaneous breathing of the patient starts after the thoracic surgery
Post-operative sore throat (1 h)
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
Post-operative hoarseness (1 h)
The incidence of hoarseness after tracheal extubation
Post-operative hoarseness (24 h)
The incidence of hoarseness after tracheal extubation
Oral dryness
The incidence of oral dryness
Dysphagia
The incidence of dysphagia

Full Information

First Posted
December 1, 2017
Last Updated
September 6, 2019
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03368599
Brief Title
Endobronchial Intubation of Double-lumen Tube: Conventional Method vs Fiberoptic Bronchoscope Guide Method
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Intratracheal, Postoperative Complications, Sore Throat, Hoarseness, Soft Tissue Injuries, Thoracic Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscope guide group
Arm Type
Experimental
Arm Description
DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement).
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
DLT is advanced blindly to the main bronchus level (Conventional advancement).
Intervention Type
Procedure
Intervention Name(s)
Bronchoscope guided advancement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional advancement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative sore throat (24 h)
Description
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most
Time Frame
24 hour after tracheal extubation
Secondary Outcome Measure Information:
Title
Resistance against DLT passage through vocal cord
Description
none/mild/severe
Time Frame
Intraoperative
Title
Resistance against DLT advancement
Description
none/mild/severe
Time Frame
Intraoperative
Title
Intubation time
Description
stop of initial mask ventilation - intubation through vocal cord
Time Frame
Intraoperative
Title
The number of attempts for intubation
Description
The number of attempts for intubation through vocal cord
Time Frame
Intraoperative
Title
The number of right misplacement of Lt. DLT
Description
The number of right misplacement of Lt. DLT confirmed using the fiberoptic bronchoscope after the advancement
Time Frame
Intraoperative
Title
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning
Description
Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus
Time Frame
Intraoperative
Title
Heart rate
Description
Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Time Frame
Intraoperative
Title
Mean arterial pressure
Description
Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Time Frame
Intraoperative
Title
IV PCA
Description
Fentanyl usage with PCA
Time Frame
At 24 hours after the extubation
Title
Airway injury (Lt. main bronhcus, carina, trachea)
Description
When spontaneous breathing of the patient starts after the thoracic surgery
Time Frame
Intraoperative
Title
Airway injury (vocal cord)
Description
When spontaneous breathing of the patient starts after the thoracic surgery
Time Frame
Intraoperative
Title
Post-operative sore throat (1 h)
Description
The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
Time Frame
24 hours after tracheal extubation
Title
Post-operative hoarseness (1 h)
Description
The incidence of hoarseness after tracheal extubation
Time Frame
1 hour after tracheal extubation
Title
Post-operative hoarseness (24 h)
Description
The incidence of hoarseness after tracheal extubation
Time Frame
24 hour after tracheal extubation
Title
Oral dryness
Description
The incidence of oral dryness
Time Frame
24 hours after tracheal extubation
Title
Dysphagia
Description
The incidence of dysphagia
Time Frame
24 hours after tracheal extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Woo Park, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7880666
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. doi: 10.1093/bja/73.6.786.
Results Reference
background
PubMed Identifier
10995141
Citation
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.
Results Reference
background
PubMed Identifier
26149601
Citation
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.
Results Reference
background
PubMed Identifier
19020122
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.
Results Reference
background
PubMed Identifier
26787799
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):282-8. doi: 10.1093/bja/aev414.
Results Reference
result
PubMed Identifier
10562789
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. doi: 10.1093/bja/82.6.920.
Results Reference
result
PubMed Identifier
16931978
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. Anesthesiology. 2006 Sep;105(3):471-7. doi: 10.1097/00000542-200609000-00009.
Results Reference
result
PubMed Identifier
32332265
Citation
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.
Results Reference
derived

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

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