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Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube

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ClinicalTrials.gov Identifier: NCT03838653
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Javier H Campos, University of Iowa

Brief Summary:
One-lung ventilation (OLV) is used for thoracic surgical procedures to facilitate surgical exposure. Lung isolation is performed using a double-lumen endotracheal tube (DLT) and optimal position is achieved with the use of fiberoptic bronchoscopy. The most common technique used to place a left-sided DLT is the blind method technique, which consists of direct laryngoscopy and rotation of the DLT into the trachea with the aim to intubate the entrance of the left main bronchus. The DLT will be rotated counterclockwise blindly after the tip of the DLT passes the vocal cords under direct laryngoscopy. However, in some occasions, the tip of the DLT migrates into the right bronchus because the alignment between the trachea and right bronchus is more vertical. The identification of the misplacement can be challenging, which could lead to the failure of lung isolation. In order to avoid the unsuccessful lung isolation, Investigators are interested in identifying the factors that potentially influence the incorrect tube DLT placement diverting into the opposite bronchus.

Condition or disease
Intubation, Intratracheal Multidetector Computed Tomography

Detailed Description:
Recently, multi-detector 3-dimensional computed tomography (MDCT) scan of the chest is becoming a routine study for patients requiring thoracic surgical procedures. On the day of thoracic surgery, the participant will be intubated with a left-sided DLT and investigators will confirm the correct insertion of the left-sided DLT at first pass under direct laryngoscopy. This information will be recorded and saved. After the study is completed, investigators will review the MDCT of the chest to review any abnormal findings and correlate it with the success of the insertion of the left-sided DLT into the left bronchus. Investigators will conduct a pilot study to determine the most influential anatomical change that leads to the DLT misplacement at the first pass based upon the changes of the tracheal-bronchial anatomy on MDCT.

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube
Actual Study Start Date : July 20, 2012
Actual Primary Completion Date : June 19, 2013
Actual Study Completion Date : June 19, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy CT Scans

Group/Cohort
Left main bronchus (LMB) intubation
Thoracic surgery patient is intubated with left side double lumen tube (L-DLT) and a fiberoptic bronchoscope is used to verify optimal positioning. The patient is designated as this group when the endobronchial lumen is observed to be in the left main bronchus (correct placement).
Right main bronchus (RMB) intubation
Thoracic surgery patient is intubated with left side double lumen tube (L-DLT) and a fiberoptic bronchoscope is used to verify optimal positioning. The patient is designated as this group when the endobronchial lumen is observed to be in the right main bronchus (incorrect placement).



Primary Outcome Measures :
  1. Measure tracheal length (mm) derived from MDCT images [ Time Frame: Within 1 month ]
    Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. Tracheal length as seen on MDCT images will be measured (millimeters) and compared between the two groups.

  2. Measure LMB diameter (mm) derived from MDCT images [ Time Frame: Within 1 month ]
    Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The LMB as seen on MDCT images will be measured (millimeters) and compared between the two groups.

  3. Measure RMB diameter (mm) derived from MDCT images [ Time Frame: Within 1 month ]
    Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The RMB as seen on MDCT images will be measured (millimeters) and compared between the two groups.

  4. Measure the tracheal LMB curvature (TLMBC) derived from MDCT images [ Time Frame: Within 1 month ]
    Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The TLMBC as seen on MDCT images will be measured and compared between the two groups. TLMBC is measured at the Trachea LMB branch point. The center lines of the airway segments (trachea and LMB) close to the branch point are displayed. A circumscribed circle goes through three adjacent airway points centered at the branch point is produced and the curvature is calculated by the reciprocal of the circle radius. The curvature of a straight line is zero. A larger curvature indicates a sharper turning angle.

  5. Measure the tracheal RMB curvature (TRMBC) derived from MDCT images [ Time Frame: Within 1 month ]
    Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The TRMBC as seen on MDCT images will be measured and compared between the two groups. TRMBC is measured at the Trachea LMB branch point. The center lines of the airway segments (trachea and RMB) close to the branch point are displayed. A circumscribed circle goes through three adjacent airway points centered at the branch point is produced and the curvature is calculated by the reciprocal of the circle radius. The curvature of a straight line is zero. A larger curvature indicates a sharper turning angle.


Secondary Outcome Measures :
  1. Calculate the TLMBC/TRMBC (TLMB/TRMB) Curvature Ratio [ Time Frame: Within 1 month ]
    Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. A ratio of the TLMBC and TRMBC values reported above will be calculated and compared between the two groups.

  2. Incidence of the DLT misplacement (RMB intubation) at the fast pass [ Time Frame: Within 10 minutes ]
    The number of times DLT misplacement (RMB intubation) at the first pass will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patient undergoing scheduled thoracic surgery at University of Iowa Hospital
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Adult patient undergoing scheduled thoracic surgery which requires left side double lumen tube placement

Exclusion Criteria:

  • More than 90 years of age
  • Patients with emergency surgery
  • Prisoners
  • Patients who cannot provide their own consent
  • Patient refusal
  • Non-English speaking patients

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): NCT03838653


Locations
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United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Javier H Campos
Investigators
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Principal Investigator: Javier H Campos, MD University of Iowa

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Responsible Party: Javier H Campos, Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03838653     History of Changes
Other Study ID Numbers: 201207717
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data (IPD) collected during the trial, after de-identification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting Materials: Study Protocol
Time Frame: Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier H Campos, University of Iowa:
Double-lumen endotracheal tube
Multidetector Computed Tomography