NCT03368599

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

December 1, 2017

Last Update Submit

September 6, 2019

Conditions

Intubation, IntratrachealPostoperative ComplicationsSore ThroatHoarsenessSoft Tissue InjuriesThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Resistance against DLT passage through vocal cord

    Intraoperative

  • Resistance against DLT advancement

    Intraoperative

  • Intubation time

    Intraoperative

  • The number of attempts for intubation

    Intraoperative

  • The number of right misplacement of Lt. DLT

    Intraoperative

  • +11 more secondary outcomes

Study Arms (2)

Bronchoscope guide group

EXPERIMENTAL

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

Procedure: Bronchoscope guided advancement

Conventional group

ACTIVE COMPARATOR

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

Procedure: Conventional advancement

Interventions

Bronchoscope guided advancementPROCEDURE

During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the bronchoscope-guided method. The method is as follows. 1. Lt. DLT is intubated through vocal cord using the direct laryngoscopy. 2. Pass the fiberoptic bronschoscope through a bronchial lumen of Lt. DLT. 3. Secure the pathway into the Lt. main bronchus by advancing the bronchoscope into the Lt. main bronchus. 4. Lt. DLT can be advanced through the guide of the bronchoscope into Lt. main bronchus. 5. 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.

Bronchoscope guide group
Conventional advancementPROCEDURE

During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the conventional method. The method is as follows. 1. Lt. DLT is intubated through vocal cord using the direct laryngoscopy. 2. Rotate Lt. DLT 90 degrees to the left side. 3. Advance Lt. DLT blindly to main bronchus level. 4. 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 group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA (American Society of Anesthesiologists) class I - III
  • Elective thoracic surgery
  • Left-sided DLT intubation for one-lung ventilation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (8)

  • 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.

    PMID: 7880666BACKGROUND

  • 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.

    PMID: 10995141BACKGROUND

  • 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.

    PMID: 26149601BACKGROUND

  • 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.

    PMID: 19020122BACKGROUND

  • 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.

    PMID: 26787799RESULT

  • 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.

    PMID: 10562789RESULT

  • 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.

    PMID: 16931978RESULT

  • 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.

    PMID: 32332265DERIVED

MeSH Terms

Conditions

Postoperative ComplicationsPharyngitisHoarsenessSoft Tissue Injuries

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiration DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryWounds and Injuries

Study Officials

  • Jin-Woo Park, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 11, 2017

Study Start

January 15, 2018

Primary Completion

January 30, 2019

Study Completion

January 31, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)