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Comparison of two methods for placement of tube and confirmation of proper tube position during intubation using left-sided double-lumen endotracheal tube: fiberoptic bronchoscopy-guided method versus conventional intubation method using Macintosh laryngoscope

Status Approved

  • First Submitted Date

    2017/12/22

  • Registered Date

    2018/01/24

  • Last Updated Date

    2018/01/08

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002663
    Unique Protocol ID CR-17-117-L
    Public/Brief Title Comparison of two methods for placement of tube and confirmation of proper tube position during intubation using left-sided double-lumen endotracheal tube: fiberoptic bronchoscopy-guided method versus conventional intubation method using Macintosh laryngoscope
    Scientific Title Comparison of two methods for placement of tube and confirmation of proper tube position during intubation using left-sided double-lumen endotracheal tube: fiberoptic bronchoscopy-guided method versus conventional intubation method using Macintosh laryngoscope
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CR-17-117
    Approval Date 2017-12-06
    Institutional Review Board Name Institutional Review Board of Daegu Catholic University Medical Center
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sung Hye Byun
    Title Assistant professor
    Telephone +82-53-650-3620
    Affiliation Daegu Catholic University Medical Center
    Address 33 Duryugongwon-ro 17-Gil, Daegu, Korea, 42472
    Contact Person for Public Queries
    Name Sung Hye Byun
    Title Assistant professor
    Telephone +82-53-650-3620
    Affiliation Daegu Catholic University Medical Center
    Address 33 Duryugongwon-ro 17-Gil, Daegu, Korea, 42472
    Contact Person for Updating Information
    Name Sung Hye Byun
    Title Assistant professor
    Telephone +82-53-650-3620
    Affiliation Daegu Catholic University Medical Center
    Address 33 Duryugongwon-ro 17-Gil, Daegu, Korea, 42472
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2017-12-18 Actual
    Target Number of Participant 50
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Daegu Catholic University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2017-12-18 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Daegu Catholic University Medical Center
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daegu Catholic University Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Identifying proper placement of double-lumen endotracheal tube (DLT) after the tracheal intubation is considerably imperative for DLT to function appropriately. For the confirmation of proper position of DLT, visual confirmation guided by fiberoptic bronchoscope (FOB) is generally considered as the gold standard.
     We hypothesized that the FOB-guided method including tracheal intubation under initial guidance of FOB via bronchial lumen and subsequent selective left bronchial intubation, would guarantee the definite placement of bronchial tip of DLT within the LMB and lessen the incidence of DLT malposition. Also, this process was expected to reduce the dissipation of the time required to confirm and correct the position of DLT, and would be more expeditious for anesthesiologist to achieve the entire process of DLT intubation. 
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Others
    (To evaluate the effectiveness of FOB guided method compared to conventional method during intubation using left sided double lumen endotracheal tube )
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    Eligible patients will be randomly assigned in equal numbers to either a conventional method (C) group or a FOB-guided method (F) group in accordance with the method of DLT placement.
    Regardless of group, all these intubation processes called DLT placement will be followed by subsequent processes called confirmation.
    
    Number of Arms 2
    Arm 1

    Arm Label

    FOB-guided method (F) group

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    For intubation in patients in F group, a FOB should be prepared being passed through the bronchial lumen of DLT in advance. And then, an anesthesiologist will introduce the FOB into the patient’s mouth while standing at the head of the bed, when a jaw-thrust maneuver will be applied to provide sufficient space for FOB passage by an experienced assistant anesthesia nurse. While positioning the FOB in the midline of pharynx during advancement, the tip should be angulated up and down to direct toward the glottis opening and advanced through the vocal cord. Once entering the trachea, the FOB will be advanced further into the LMB and the previously loaded DLT will be inserted into the LMB guided by FOB with jaw thrust maintained. During withdrawal of the FOB through the bronchial lumen, the position of the DLT should be checked and corrected for the bronchial cuff not to advance beyond secondary carina while checking via FOB. The bronchial tip is considered be proper to be placed approximately 1 cm above the secondary carina. Same as in the F group, after the placement of DLT, the anesthesiologist will perform the confirmation processes.
    Arm 2

    Arm Label

    Conventional method (C) group

    Target Number of Participant

    25

    Arm Type

    Active comparator

    Arm Description

    In patients in C group, all intubations will be performed with DLT preformed over the stylet and the DLT should be bent to approximately 90 degrees at a point of the tracheal balloon. After the bronchial tip of the DLT will pass beyond the vocal cords under direct laryngoscopy, the stylet will be removed, and the DLT will be rotated 90 degrees to the left and then advanced until slight resistance will be encountered. Regardless of group, all these intubation processes called DLT placement will be followed by subsequent processes called confirmation.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C34.99)Malignant neoplasm of bronchus or lung, unspecified, unspecified side 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~70Year

    Description

    1. Scheduled for elective thoracic surgery for which a left-sided DLT required
    2. Patients aged 18–70 years with an American Society of Anesthesiologists physical status (ASA) I or II 
    3. Willingness to participate in and comply with the study.
    Exclusion Criteria
    1. Patients required a right-sided DLT 
    2. Presence of an intraluminal lesion in the LMB 
    3. Presence of an anatomical problem of the tracheobronchial tree on chest radiography 
    4. Patient with body mass index greater than 30 kg/m²
    5. Limitation of neck motion 
    6. Reduced mouth opening (less than 3 cm)
    7. Poor dental status 
    8. Mallampati class IV (soft palate not visible at all while sitting up straight, mouth open and tongue maximally protruded)
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    the incidence of DLT malposition, observed by FOB 
    Timepoint
    during confirmation process just after placement of DLT within left main bronchus
    Secondary Outcome(s) 1
    Outcome
    the time for total procedure defines as the time required to achieve the entire process of intubation using DLT
    Timepoint
    during the entire process of intubation using DLT
    Secondary Outcome(s) 2
    Outcome
    the incidence of the failed tracheal intubation on first attempt 
    Timepoint
    during the entire process of intubation using DLT
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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