Endobronchial Intubation of Double-lumen Tube: Conventional Method vs Fiberoptic Bronchoscope Guide Method
- Conditions
- Sore ThroatPostoperative ComplicationsHoarsenessThoracic SurgeryIntubation, IntratrachealSoft Tissue Injuries
- Interventions
- Procedure: Bronchoscope guided advancementProcedure: Conventional advancement
- Registration Number
- NCT03368599
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- ASA (American Society of Anesthesiologists) class I - III
- Elective thoracic surgery
- Left-sided DLT intubation for one-lung ventilation
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bronchoscope guide group Bronchoscope guided advancement DLT is advanced into the main bronchus through the guide of fiberoptic bronchoscope (Bronchoscope guided advancement). Conventional group Conventional advancement DLT is advanced blindly to the main bronchus level (Conventional advancement).
- Primary Outcome Measures
Name Time Method Post-operative sore throat (24 h) 24 hour after tracheal extubation The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most
- Secondary Outcome Measures
Name Time Method IV PCA At 24 hours after the extubation Fentanyl usage with PCA
Heart rate Intraoperative Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Resistance against DLT passage through vocal cord Intraoperative none/mild/severe
Intubation time Intraoperative stop of initial mask ventilation - intubation through vocal cord
Airway injury (Lt. main bronhcus, carina, trachea) Intraoperative When spontaneous breathing of the patient starts after the thoracic surgery
Mean arterial pressure Intraoperative Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Airway injury (vocal cord) Intraoperative When spontaneous breathing of the patient starts after the thoracic surgery
The number of attempts for intubation Intraoperative The number of attempts for intubation through vocal cord
Post-operative sore throat (1 h) 24 hours after tracheal extubation The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
Dysphagia 24 hours after tracheal extubation The incidence of dysphagia
Resistance against DLT advancement Intraoperative none/mild/severe
The number of right misplacement of Lt. DLT Intraoperative 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 Intraoperative Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus
Post-operative hoarseness (1 h) 1 hour after tracheal extubation The incidence of hoarseness after tracheal extubation
Post-operative hoarseness (24 h) 24 hour after tracheal extubation The incidence of hoarseness after tracheal extubation
Oral dryness 24 hours after tracheal extubation The incidence of oral dryness
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of