Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03782090
Recruitment Status : Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intubation Tube(Intubation Using Double Lumen Endobronchial Tube) Device: Endobronchial intubation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Single (Participant)
Masking Description: Patients, investigators who evaluate complication of intubation are blinded to the study group.
Primary Purpose: Other
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
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: Control
Endobronchial intubation using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA)
Device: Endobronchial intubation
  1. 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.
  2. 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.

Experimental: Experimental
Endobronchial intubation using novel left-sided double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea)
Device: Endobronchial intubation
  1. 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.
  2. 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.




Primary Outcome Measures :
  1. Optimal position of double-lumen endobronchial tube [ Time Frame: 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 :
  1. The corrected depth of endobronchial tube [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782090


Locations
Layout table for location information
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Severance
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03782090     History of Changes
Other Study ID Numbers: 4-2018-0698
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No