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Anticipation of depth of double-lumen endobronchial tube in the patients undergone elective thoracic surgery: a retrospective study

Status Approved

First Submitted Date

2021/02/26
Registered Date

2021/03/05
Last Updated Date

2021/02/26

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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	KCT0005966
Unique Protocol ID	EUMC 2020-09-015
Public/Brief Title	Anticipation of depth of double-lumen endobronchial tube in the patients undergone elective thoracic surgery: a retrospective study
Scientific Title	Anticipation of depth of double-lumen endobronchial tube in the patients undergone elective thoracic surgery: a retrospective study
Acronym	DLT depth
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	EUMC 2020-09-015
Approval Date	2020-10-19
Institutional Review Board Name	Institutional Review Board, Mokdong Hospital, EUMC
Institutional Review Board Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Institutional Review Board Telephone	02-2650-5872
Data Monitoring Committee	No

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	Jong Wha Lee
Title	MD
Telephone	+82-2-2650-5560
Affiliation	Ewha Womans University Medical Center
Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Contact Person for Public Queries
Name	Jong Wha Lee
Title	MD
Telephone	+82-2-2650-5560
Affiliation	Ewha Womans University Medical Center
Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Contact Person for Updating Information
Name	Jong Wha Lee
Title	MD
Telephone	+82-2-2650-5560
Affiliation	Ewha Womans University Medical Center
Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2020-10-19 Actual
Target Number of Participant	575
Primary Completion Date	2021-01-01 , Actual
Study Completion Date	2021-01-01 , Actual
Name of Study	Ewha Womans University Medical Center
Recruitment Status	Completed
Date of First Enrollment	2020-10-19 ,

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	Ewha Womens University
Organization Type	University
Project ID	EUMC 2020-09-015

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ewha Womens University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	As video-assisted thoracoscopic surgery (VATS) is preferentially employed for thoracic surgery, one-lung ventilation (OLV) is mandatory for surgical exposure. Therefore, proper placement of bronchial limb of double-lumen endobronchial tube (DLT) has been regarded as a vital phase of the OLV procedure. Depth of DLT, which is an important marker for initial placement of DLT, is reportedly known to be directly proportional to patient’s height. But we have a concern for general applicability of height in patients with various body contour. In the current investigation, the authors designed retrospective study to analyze data from patients whose tracheas were intubated with left-sided DLT for operations requiring OLV. By analyzing pooled data, the authors hypothesized that a clinically available guide to predict initial depth of DLT appropriately, especially in patients with ethnic specificity. Additionally, acting anaesthetists whose performances were included into the analysis were asked to complete a simple questionnaire on how they perform the endobronchial intubation. It was designed to find out whether there is a gap between the everyday practice of acting anaesthetists and clinical recommendations suggested by literatures on height-based formulae.

Study Summary Information

Lay Summary

As video-assisted thoracoscopic surgery (VATS) is preferentially employed for thoracic surgery, one-lung ventilation (OLV) is mandatory for surgical exposure. Therefore, proper placement of bronchial limb of double-lumen endobronchial tube (DLT) has been regarded as a vital phase of the OLV procedure.
Depth of DLT, which is an important marker for initial placement of DLT, is reportedly known to be directly proportional to patient’s height. But we have a concern for general applicability of height in patients with various body contour. In the current investigation, the authors designed retrospective study to analyze data from patients whose tracheas were intubated with left-sided DLT for operations requiring OLV. By analyzing pooled data, the authors hypothesized that a clinically available guide to predict initial depth of DLT appropriately, especially in patients with ethnic specificity. Additionally, acting anaesthetists whose performances were included into the analysis were asked to complete a simple questionnaire on how they perform the endobronchial intubation. It was designed to find out whether there is a gap between the everyday practice of acting anaesthetists and clinical recommendations suggested by literatures on height-based formulae.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	575
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Electronic medical records of adult patients (≥20 years of age), who required endobronchial intubation with DLT for OLV over a three-year period from Feb 2018 to Dec 2020, were reviewed
Cohort/ Group 1	Cohort/Group Description Electronic medical records of adult patients (≥20 years of age), who required endobronchial intubation with DLT for OLV over a three-year period from Feb 2018 to Dec 2020, were reviewed.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Electronic medical records of adult patients (≥20 years of age), who required endobronchial intubation with DLT for OLV over a three-year period from Feb 2018 to Dec 2020, were reviewed.
Sampling Method	Electronic medical records of adult patients (≥20 years of age), who required endobronchial intubation with DLT for OLV over a three-year period from Feb 2018 to Dec 2020, were reviewed and retrieved data on DLT insertion.
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J95.1)Acute pulmonary insufficiency following thoracic surgery video-assisted throacoscopic surgery; one-lung ventilation; double-lumen endobronchial tube
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~99Year
	Description Electronic medical records of adult patients (≥20 years of age), who required endobronchial intubation with DLT for OLV over a three-year period from Feb 2018 to Dec 2020, were reviewed.
Exclusion Criteria	When a patient had more than 2 consecutive operations requiring OLV during study period, the latest operation was only included.And if there is a record of failure of OLV or no record of DLT insertion, that record is excluded.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	depth of DLT in supine position, depth of DLT in lateral decubitus position
Timepoint	When the anesthesia is induced, and DLT is inserted
Secondary Outcome(s) 1
Outcome	size of DLT
Timepoint	When the anesthesia is induced, and DLT is inserted

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	No

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	No

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