Therapeutic Procedural ComplicationNCT03008473
Chest CT for the Placement of the Uniblocker
A study testing video laryngoscope and chest CT iminge and Conventional intubation of uniblocker in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
Video laryngoscope and chest CT iminge for the placement of the Uniblocker Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- video laryngoscope and chest CT iminge and Conventional intubation of uniblocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to 24 Sep 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 65 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 Under general anesthesia
Who cannot join
- Age younger than 18 yr or older than 65 yr
- 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
Official title: Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography
Video laryngoscope and chest CT iminge for the placement of the Uniblocker
Read the detailed description
Comparing the traditional method of Uniblocker intubation and video laryngoscope combined with chest CT iminge guide the precise localization of Uniblocker
- Conditions
- Therapeutic Procedural Complication
- Being tested
- video laryngoscope and chest CT iminge, Conventional intubation of uniblocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video laryngoscope and chest CT imingeDevice
Conventional intubation of uniblockerDevice
| Study group | Role | What they receive |
|---|---|---|
| video laryngoscope and chest CT iminge | Experimental | First,the operator calculate the distance between the carina and the glottis by CT image and make a marker on the Uniblocker. Then the operator inserted the Uniblocker into the trachea and advanced toward the left main-stem bronchus via the video laryngoscope untill see marker just at the glottis then stopped the insertion .Second, a single lumen tube with appropriate size was intubated via video laryngoscope into the appropriate depth.Third,the Fiberoptic bronchoscopy(FOB) was inserted into single lumen tube to assess the position of the Uniblocker and the injuries of bronchi and carina Receives: Device: video laryngoscope and chest CT iminge |
| Conventional intubation of Uniblocker | Experimental | First, a conventional single lumen tube (SLT) was inserted into trachea at optimal depth via video laryngoscope. Second, a Uniblocker was inserted through SLT and directed to the left main-stem bronchus. Third, an FOB was inserted into the SLT to adjust the Uniblocker to optimal position and assessed the injuries of bronchi and carina. Receives: Device: Conventional intubation of uniblocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
Measured: 5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion24 Sep 2017
- Study completion24 Sep 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, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ximing Qi, PHD, Study director, The First Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008473
- Sponsor's protocol ID
- 20161229
- Status last verified
- Dec 2016
- First submitted
- 29 Dec 2016
- Last updated
- 23 Feb 2018
- 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography
- ClinicalTrials.gov ID
- NCT03008473
- Acronym / sponsor ID
- 20161229
- Conditions
- Therapeutic Procedural Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- 24 Sep 2017 (actual)
- Study completion
- 24 Sep 2017 (actual)
- First posted
- 2 Jan 2017 (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.
Video laryngoscope and chest CT iminge for the placement of the Uniblocker
Detailed description
Comparing the traditional method of Uniblocker intubation and video laryngoscope combined with chest CT iminge guide the precise localization of Uniblocker
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video laryngoscope and chest CT iminge | Experimental | Device: video laryngoscope and chest CT imingeFirst,the operator calculate the distance between the carina and the glottis by CT image and make a marker on the Uniblocker. Then the operator inserted the Uniblocker into the trachea and advanced toward the left main-stem bronchus via the video laryngoscope untill see marker just at the glottis then stopped the insertion .Second, a single lumen tube with appropriate size was intubated via video laryngoscope into the appropriate depth.Third,the Fiberoptic bronchoscopy(FOB) was inserted into single lumen tube to assess the position of the Uniblocker and the injuries of bronchi and carina |
| Conventional intubation of Uniblocker | Experimental | Device: Conventional intubation of uniblockerFirst, a conventional single lumen tube (SLT) was inserted into trachea at optimal depth via video laryngoscope. Second, a Uniblocker was inserted through SLT and directed to the left main-stem bronchus. Third, an FOB was inserted into the SLT to adjust the Uniblocker to optimal position and assessed the injuries of bronchi and carina. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia
Key exclusion criteria (3 listed)
- Age younger than 18 yr or older than 65 yr
- 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 |
|---|---|---|
| video laryngoscope and chest CT iminge | Device | video laryngoscope and chest CT iminge |
| Conventional intubation of uniblocker | Device | Conventional intubation of Uniblocker |
Primary outcome
Intubation Time
Time frame: 5min
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 23 Feb 2018.
- 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, PHD 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 video laryngoscope and chest CT iminge and Conventional intubation of uniblocker 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 3 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 23 Feb 2018. 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: 5min). 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 23 Feb 2018.