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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bronchoscope guide group

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

Group Type EXPERIMENTAL

Bronchoscope guided advancement

Intervention Type PROCEDURE

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.

Conventional group

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

Group Type ACTIVE_COMPARATOR

Conventional advancement

Intervention Type PROCEDURE

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.

Interventions

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Bronchoscope guided advancement

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.

Intervention Type PROCEDURE

Conventional advancement

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No