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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03368599
Enrollment
136
Registered
2017-12-11
Start date
2018-01-15
Completion date
2019-01-31
Last updated
2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

PROCEDUREBronchoscope 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.

PROCEDUREConventional 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.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative sore throat (24 h)24 hour after tracheal extubationThe degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most

Secondary

MeasureTime frameDescription
Intubation timeIntraoperativestop of initial mask ventilation - intubation through vocal cord
Resistance against DLT passage through vocal cordIntraoperativenone/mild/severe
Resistance against DLT advancementIntraoperativenone/mild/severe
The number of right misplacement of Lt. DLTIntraoperativeThe 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 positioningIntraoperativeTime for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus
Heart rateIntraoperativeHeart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
Mean arterial pressureIntraoperativeMean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning
The number of attempts for intubationIntraoperativeThe number of attempts for intubation through vocal cord
Airway injury (Lt. main bronhcus, carina, trachea)IntraoperativeWhen spontaneous breathing of the patient starts after the thoracic surgery
Airway injury (vocal cord)IntraoperativeWhen spontaneous breathing of the patient starts after the thoracic surgery
Post-operative sore throat (1 h)24 hours after tracheal extubationThe degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation
Post-operative hoarseness (1 h)1 hour after tracheal extubationThe incidence of hoarseness after tracheal extubation
Post-operative hoarseness (24 h)24 hour after tracheal extubationThe incidence of hoarseness after tracheal extubation
Oral dryness24 hours after tracheal extubationThe incidence of oral dryness
Dysphagia24 hours after tracheal extubationThe incidence of dysphagia
IV PCAAt 24 hours after the extubationFentanyl usage with PCA

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026