Intubation, Intratracheal Clinical Trial
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
NCT number | NCT03838653 |
Other study ID # | 201207717 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 20, 2012 |
Est. completion date | June 19, 2013 |
Verified date | February 2019 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | June 19, 2013 |
Est. primary completion date | June 19, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Javier H Campos |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure tracheal length (mm) derived from MDCT images | 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. | Within 1 month | |
Primary | Measure LMB diameter (mm) derived from MDCT images | 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. | Within 1 month | |
Primary | Measure RMB diameter (mm) derived from MDCT images | 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. | Within 1 month | |
Primary | Measure the tracheal LMB curvature (TLMBC) derived from MDCT images | 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. | Within 1 month | |
Primary | Measure the tracheal RMB curvature (TRMBC) derived from MDCT images | 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. | Within 1 month | |
Secondary | Calculate the TLMBC/TRMBC (TLMB/TRMB) Curvature Ratio | 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. | Within 1 month | |
Secondary | Incidence of the DLT misplacement (RMB intubation) at the fast pass | The number of times DLT misplacement (RMB intubation) at the first pass will be recorded. | Within 10 minutes |
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