Skip to main content
OpenTrials
Completed

NCT Number: NCT03368599

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

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

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bronchoscope guided advancement

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2017
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.