Clinical trial NCT03782090: Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation
Official title: Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endotracheal tube (Ankor®,Insung Medical, Wonjou, S. Korea).
Primary purpose: OTHER

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Optimal position of double-lumen endobronchial tube
timeFrame: 1 day (after intubation)
Secondary outcomes:
measure: The corrected depth of endobronchial tube
timeFrame: 1 day (after intubation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance
Study officials:
References: