Clinical trial NCT03368599: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Postoperative Complications
Sore Throat
Hoarseness
Soft Tissue Injuries
Thoracic Surgery
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Post-operative sore throat (24 h)
timeFrame: 24 hour after tracheal extubation
Secondary outcomes:
measure: Resistance against DLT passage through vocal cord
timeFrame: Intraoperative
measure: Resistance against DLT advancement
timeFrame: Intraoperative
measure: Intubation time
timeFrame: Intraoperative
measure: The number of attempts for intubation
timeFrame: Intraoperative
measure: The number of right misplacement of Lt. DLT
timeFrame: Intraoperative
measure: Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning
timeFrame: Intraoperative
measure: Heart rate
timeFrame: Intraoperative
measure: Mean arterial pressure
timeFrame: Intraoperative
measure: IV PCA
timeFrame: At 24 hours after the extubation
measure: Airway injury (Lt. main bronhcus, carina, trachea)
timeFrame: Intraoperative
measure: Airway injury (vocal cord)
timeFrame: Intraoperative
measure: Post-operative sore throat (1 h)
timeFrame: 24 hours after tracheal extubation
measure: Post-operative hoarseness (1 h)
timeFrame: 1 hour after tracheal extubation
measure: Post-operative hoarseness (24 h)
timeFrame: 24 hour after tracheal extubation
measure: Oral dryness
timeFrame: 24 hours after tracheal extubation
measure: Dysphagia
timeFrame: 24 hours after tracheal extubation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin-Woo Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.