Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation

Not Applicable

Completed

• Conditions: Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)
• Interventions: Device: Endobronchial intubation

• Registration Number: NCT03782090
• Lead Sponsor: Yonsei University

Brief Summary

The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. The size of endobronchial tube is decided based on the diameter of left main bronchus measured on the CT finding of patients. After induction of general anesthesia, in patients assigned to control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after the tube is rotated 90º toward the left. The tube is advanced until slight resistance is felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not in optimal position, the depth of tube is corrected to optimal position under guidance of fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before extubation. The success of endobronchial intubation, position of endobronchial tube, the corrected depth of endobronchial tube, time consumption for endobronchial intubation and complication of intubation such as airway injury, pain, and hoarseness are compared between two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-05
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. ASA classification 1-3
2. aged between 20 to 85
3. undergoing one lung ventilation using left-sided double-lumen endobronchial tube for thoracic surgery

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Exclusion Criteria

1. Expected difficult intubation (neck extension<35 degrees, mandibular-hyoid distance < 6 cm, sternomental distance < 12.5 cm)
2. anomaly of tracheobronchial tree
3. intraluminal lesion in left or right bronchus
4. Obesity (Body Mass Index > 30)
5. upper respiratory infection
6. Thoracic surgical history
7. blood coagulation disorder
8. emergency operation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Endobronchial intubation	Endobronchial intubation using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA)
Experimental	Endobronchial intubation	Endobronchial intubation using novel left-sided double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea)

Primary Outcome Measures

Name	Time	Method
Optimal position of double-lumen endobronchial tube	1 day (after intubation)	On fiberoptic bronchoscopic view after intubation, optimal position of double-lumen endobronchial tube is defined when the bronchial cuff of the tube is immediately below the tracheal carina and there is a clear view of the left subcarina with unobstructed left upper and lower bronchi.

Secondary Outcome Measures

Name	Time	Method
The corrected depth of endobronchial tube	1 day (after intubation)	The corrected depth of endobronchial tube is defined as the difference between the depth of endobronchial tube before and after the depth of tube is corrected to optimal position under guidance of fiberoptic.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Severance; 🇰🇷 Seoul, Korea, Republic of