Therapeutic Procedural ComplicationNCT04127903
The Length of the Right Main Stem Bronchus as a Guide to Right-sided Double-lumen Tube Use
A study testing the Length of Right Main Stem Bronchus in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- the Length of Right Main Stem Bronchus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to 24 Apr 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing thoracic surgery
Who cannot join
- Age>70 or <18 years
- ASA classifications >III
- BMI >35kg/m2
- Modified Mallampati classification ≥III
- Thoracic surgery within the last one month
- Severe cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.
The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use
Read the detailed description
The double lumen tube (DLT) is the most popular way to isolate the lungs for thoracic surgery. The variable anatomy of the length of the right main stem bronchus seems to be the main reason clinicians are unwilling to use the right-sided DLT (R-DLT). The factors that could compromise the adequate ventilation of the right lung are mostly the variable length of the Right Main Stem Bronchus and the misalignment of the lateral orifice of the right-sided DLT in regard to the right upper lobe bronchus (RULB). The objectives of this study were to validate an alternative method to estimate the length of the Right Main Stem Bronchus by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use
- Conditions
- Therapeutic Procedural Complication
- Being tested
- the Length of Right Main Stem Bronchus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Length of Right Main Stem BronchusOther
The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography
| Study group | Role | What they receive |
|---|---|---|
| the Length of Right Main Stem Bronchus >=15mm | Experimental | Not described Receives: Other: the Length of Right Main Stem Bronchus |
| the Length of Right Main Stem Bronchus <15mm | Experimental | Not described Receives: Other: the Length of Right Main Stem Bronchus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Uniblocker displacement
Measured: 1 year
The number of adjust the right-sided double-lumen tube to optimum location
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start15 Oct 2019
- Primary completion20 Feb 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Procedural ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ximing Qi, Study director, The First Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127903
- Sponsor's protocol ID
- 2019A123
- Status last verified
- Feb 2023
- First submitted
- 13 Oct 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Z, Liu M, Zhao L, Qi X, Yu Y, Liang S, Yang X, Ma Z. Comparison of the accuracy of three methods measured the length of the right main stem bronchus by chest computed tomography as a guide to the use of right sided double-lumen tube. BMC Anesthesiol. 2022 Aug 18;22(1):264. doi: 10.1186/s12871-022-01744-z.
PubMed 35982403
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.
- ClinicalTrials.gov ID
- NCT04127903
- Acronym / sponsor ID
- 2019A123
- Conditions
- Therapeutic Procedural Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 16 Oct 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.
The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use
Detailed description
The double lumen tube (DLT) is the most popular way to isolate the lungs for thoracic surgery. The variable anatomy of the length of the right main stem bronchus seems to be the main reason clinicians are unwilling to use the right-sided DLT (R-DLT). The factors that could compromise the adequate ventilation of the right lung are mostly the variable length of the Right Main Stem Bronchus and the misalignment of the lateral orifice of the right-sided DLT in regard to the right upper lobe bronchus (RULB). The objectives of this study were to validate an alternative method to estimate the length of the Right Main Stem Bronchus by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Length of Right Main Stem Bronchus >=15mm | Experimental | Other: the Length of Right Main Stem Bronchus |
| the Length of Right Main Stem Bronchus <15mm | Experimental | Other: the Length of Right Main Stem Bronchus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing thoracic surgery
Key exclusion criteria (6 listed)
- Age>70 or <18 years
- ASA classifications >III
- BMI >35kg/m2
- Modified Mallampati classification ≥III
- Thoracic surgery within the last one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Length of Right Main Stem BronchusThe distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography | Other | the Length of Right Main Stem Bronchus <15mm, the Length of Right Main Stem Bronchus >=15mm |
Primary outcome
The incidence of Uniblocker displacement
Time frame: 1 year
The number of adjust the right-sided double-lumen tube to optimum location
Time frame: 1 year
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 15 Feb 2023.
- Derived from this study: PubMed 35982403Liu Z, Liu M, Zhao L, Qi X, Yu Y, Liang S, Yang X, Ma Z. Comparison of the accuracy of three methods measured the length of the right main stem bronchus by chest computed tomography as a guide to the use of right sided double-lumen tube. BMC Anesthesiol. 2022 Aug 18;22(1):264. doi: 10.1186/s12871-022-01744-z.
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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.
Ximing Qi study director
The First Hospital of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Length of Right Main Stem Bronchus in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
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 1 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 15 Feb 2023. 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 China. 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?
The incidence of Uniblocker displacement (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127903, which also lists 1 linked publication.
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 15 Feb 2023.