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
CRIS Registration Number |
KCT0002663 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Daegu Catholic University Medical Center |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Daegu Catholic University Medical Center |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C34.99)Malignant neoplasm of bronchus or lung, unspecified, unspecified side |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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