Intubation, IntratrachealNCT03838653
Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube
An observational study of Intubation, Intratracheal and Multidetector Computed Tomography, run by Javier H Campos at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation, Intratracheal, Multidetector Computed Tomography
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2012to 19 Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient undergoing scheduled thoracic surgery at University of Iowa Hospital
Who may be able to join
- At least 18 years of age
- Adult patient undergoing scheduled thoracic surgery which requires left side double lumen tube placement
Who cannot join
- More than 90 years of age
- Patients with emergency surgery
- Prisoners
- Patients who cannot provide their own consent
- Patient refusal
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Keywords
- Double-lumen endotracheal tube, Multidetector Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 month
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.
Measured: Within 1 month
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.
Measured: Within 1 month
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.
Measured: Within 1 month
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.
Measured: Within 1 month
Secondary outcomes (2)
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.
Measured: Within 1 month
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.
Measured: Within 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start20 Jul 2012
- Primary completion19 Jun 2013
- Study completion19 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javier H Campos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier H Campos, University of Iowa
- Investigators
- Javier H Campos, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838653
- Sponsor's protocol ID
- 201207717
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03838653
- Acronym / sponsor ID
- 201207717
- Keywords
- Double-lumen endotracheal tube, Multidetector Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Javier H CamposUniversity, hospital or other
- Study start
- 20 Jul 2012 (actual)
- Primary completion
- 19 Jun 2013 (actual)
- Study completion
- 19 Jun 2013 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient undergoing scheduled thoracic surgery at University of Iowa Hospital
Key inclusion criteria (2 listed)
- At least 18 years of age
- Adult patient undergoing scheduled thoracic surgery which requires left side double lumen tube placement
Key exclusion criteria (6 listed)
- More than 90 years of age
- Patients with emergency surgery
- Prisoners
- Patients who cannot provide their own consent
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Calculate the TLMBC/TRMBC (TLMB/TRMB) Curvature Ratio
Time frame: Within 1 month
Incidence of the DLT misplacement (RMB intubation) at the fast pass
Time frame: Within 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier H Campos, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, Intratracheal and Multidetector Computed Tomography, run by Javier H Campos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure tracheal length (mm) derived from MDCT images (time frame: Within 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.