Postoperative Complications Clinical Trial
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
Verified date | September 2019 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 136 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital |
Korea, Republic of,
Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7. — View Citation
Cheong KF, Koh KF. Placement of left-sided double-lumen endobronchial tubes: comparison of clinical and fibreoptic-guided placement. Br J Anaesth. 1999 Jun;82(6):920-1. — View Citation
Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. — View Citation
Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesi — View Citation
McHardy FE, Chung F. Postoperative sore throat: cause, prevention and treatment. Anaesthesia. 1999 May;54(5):444-53. Review. — View Citation
Park SH, Han SH, Do SH, Kim JW, Rhee KY, Kim JH. Prophylactic dexamethasone decreases the incidence of sore throat and hoarseness after tracheal extubation with a double-lumen endobronchial tube. Anesth Analg. 2008 Dec;107(6):1814-8. doi: 10.1213/ane.0b013e318185d093. — View Citation
Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative sore throat (24 h) | The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most | 24 hour after tracheal extubation | |
Secondary | Resistance against DLT passage through vocal cord | none/mild/severe | Intraoperative | |
Secondary | Resistance against DLT advancement | none/mild/severe | Intraoperative | |
Secondary | Intubation time | stop of initial mask ventilation - intubation through vocal cord | Intraoperative | |
Secondary | The number of attempts for intubation | The number of attempts for intubation through vocal cord | Intraoperative | |
Secondary | The number of right misplacement of Lt. DLT | The number of right misplacement of Lt. DLT confirmed using the fiberoptic bronchoscope after the advancement | Intraoperative | |
Secondary | Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning | Time for DLT positioning: stop of initial mask ventilation - success of the 1st fine DLT positioning into Lt. main bronchus | Intraoperative | |
Secondary | Heart rate | Heart rate Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning | Intraoperative | |
Secondary | Mean arterial pressure | Mean arterial pressure Just before Lt. DLT intubation / 2 min after success of the 1st fine DLT positioning | Intraoperative | |
Secondary | IV PCA | Fentanyl usage with PCA | At 24 hours after the extubation | |
Secondary | Airway injury (Lt. main bronhcus, carina, trachea) | When spontaneous breathing of the patient starts after the thoracic surgery | Intraoperative | |
Secondary | Airway injury (vocal cord) | When spontaneous breathing of the patient starts after the thoracic surgery | Intraoperative | |
Secondary | Post-operative sore throat (1 h) | The degree of throat pain (Visual Analogue Scale (VAS); 0, no pain; 10, most pain) after tracheal extubation | 24 hours after tracheal extubation | |
Secondary | Post-operative hoarseness (1 h) | The incidence of hoarseness after tracheal extubation | 1 hour after tracheal extubation | |
Secondary | Post-operative hoarseness (24 h) | The incidence of hoarseness after tracheal extubation | 24 hour after tracheal extubation | |
Secondary | Oral dryness | The incidence of oral dryness | 24 hours after tracheal extubation | |
Secondary | Dysphagia | The incidence of dysphagia | 24 hours after tracheal extubation |
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