Therapeutic Procedural ComplicationNCT02943928
Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance
A study testing laryngoscope and chest CT image and traditional method by experience in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning 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?
- laryngoscope and chest CT image and traditional method by experience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Mar 2017
- 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
- BMI less than 35 kg/m2
- ASA classifications of I-III, modified Mallampati classification 1 or 2 general anesthesia were included-
Who cannot join
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions-
Trial locations and contacts
1 site in 1 country.
About this study
laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning
Read the detailed description
Comparing the traditional method of double lumen endotracheal tube intubation and laryngoscope combined with chest CT guide the precise localization of double lumen endotracheal tube
- Conditions
- Therapeutic Procedural Complication
- Being tested
- laryngoscope and chest CT image, traditional method by experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscope and chest CT imageDevice
First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis
traditional method by experienceDevice
Operator inserted the double lumen tube by experience
| Study group | Role | What they receive |
|---|---|---|
| laryngoscope and chest CT image | Experimental | First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis. Receives: Device: laryngoscope and chest CT image |
| Traditional method by experience | Experimental | Operator inserted the double lumen tube by experience Receives: Device: traditional method by experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
Measured: Ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT02943928
- Sponsor's protocol ID
- 2016A123
- Status last verified
- Feb 2023
- First submitted
- 23 Oct 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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
- Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance
- ClinicalTrials.gov ID
- NCT02943928
- Acronym / sponsor ID
- 2016A123
- Conditions
- Therapeutic Procedural Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Oct 2016 (estimated)
- 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.
laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning
Detailed description
Comparing the traditional method of double lumen endotracheal tube intubation and laryngoscope combined with chest CT guide the precise localization of double lumen endotracheal tube
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laryngoscope and chest CT image | Experimental | Device: laryngoscope and chest CT imageFirst,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis. |
| Traditional method by experience | Experimental | Device: traditional method by experienceOperator inserted the double lumen tube by experience |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI less than 35 kg/m2
- ASA classifications of I-III, modified Mallampati classification 1 or 2 general anesthesia were included-
Key exclusion criteria (2 listed)
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions-
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 |
|---|---|---|
| laryngoscope and chest CT imageFirst,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis | Device | laryngoscope and chest CT image |
| traditional method by experienceOperator inserted the double lumen tube by experience | Device | Traditional method by experience |
Primary outcome
Intubation Time
Time frame: Ten 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 15 Feb 2023.
- Individual participant dataSharing planned: Yes
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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 laryngoscope and chest CT image and traditional method by experience 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 2 inclusion and 2 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?
Intubation Time (time frame: Ten minutes). 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 15 Feb 2023.