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

Intubation Tube(Intubation Using Double Lumen Endobronchial Tube) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782090
• Other study ID #: 4-2018-0698
• Status: Completed
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)

Intervention

Device:
• Endobronchial intubation
In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube(Shiley®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. The tube is advanced according to the depth(cm) of the tube calculated by the height of patient(12.5+0.1*height). Afterwards, the depth of the tube is adjusted by the compliance of both lung. In experimental group, patients are intubated with novel double-lumen endobronchial tube(Ankor®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. Once the carinal cuff of the tube is passed through the vocal cord of patients, the carinal cuff is inflated with 5-8ml of air. The tube is advanced until the tube stops itself at some point along the tracheobronchial tree. And then the carinal cuff is deflated.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal position of double-lumen endobronchial tube	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.	1 day (after intubation)
Secondary	The corrected depth of endobronchial tube	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.	1 day (after intubation)