Therapeutic Procedural ComplicationNCT03392818
An Innovative Approach for Uniblocker Intubation
A study testing The measured distance, formula and Fiberoptic bronchoscope in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB. 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 measured distance, formula and Fiberoptic bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2018to Jun 2018
- 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 left side thoracic surgery
- The thoracic surgery requiring a Uniblocker for one-lung ventilation
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.
Yang Li contact
China1 site, 1 recruiting
- Recruiting
The first hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Zhuo Liu, +86-03355908581, liuzhuo2011@yeah.net
About this study
Official title: An Innovative Approach for Accurately Predicting the Optimal Insertion Depth of Uniblocker Without Fiberoptic Bronchoscope Assistance
To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.
Read the detailed description
In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.
- Conditions
- Therapeutic Procedural Complication
- Being tested
- The measured distance, formula, Fiberoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The measured distanceOther
To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of Fiberoptic bronchoscope.
formulaOther
Calculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423
Fiberoptic bronchoscopeDevice
The intubation of Uniblocker under the guidance of Fiberoptic bronchoscope
| Study group | Role | What they receive |
|---|---|---|
| formula | Experimental | Calculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423 Receives: Other: formula |
| Fiberoptic bronchoscope | Experimental | intubation of Uniblocker under the Under the guidance of Fiberoptic bronchoscope Receives: Device: Fiberoptic bronchoscope |
| The measured distance | Experimental | To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB. Receives: Other: The measured distance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intubation time
The intubation time defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until Uniblocker at the optimal position and this was done using a stopwatch.
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 posted8 Jan 2018
- Study start7 Jan 2018
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
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
- NCT03392818
- Sponsor's protocol ID
- 966169
- Status last verified
- Dec 2017
- First submitted
- 24 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Approach for Accurately Predicting the Optimal Insertion Depth of Uniblocker Without Fiberoptic Bronchoscope Assistance
- ClinicalTrials.gov ID
- NCT03392818
- Acronym / sponsor ID
- 966169
- Conditions
- Therapeutic Procedural Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Jan 2018 (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.
To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina was calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.
Detailed description
In previous study, the investigators found Chest computed tomography (CT) image can accurately predicting the optimal insertion depth of Uniblocker,however in some hospital the CT scan performed for the preoperative surgical evaluation without the vocal cords slices. If a more extensive CT scan was needed for obtaining a more reliable image of the vocal cords,the additional exposure dose would be a major disadvantage of the method.So the investigators measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| formula | Experimental | Other: formulaCalculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423 |
| Fiberoptic bronchoscope | Experimental | Device: Fiberoptic bronchoscopeintubation of Uniblocker under the Under the guidance of Fiberoptic bronchoscope |
| The measured distance | Experimental | Other: The measured distanceTo measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of FOB. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing left side thoracic surgery
- The thoracic surgery requiring a Uniblocker for one-lung ventilation
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 measured distanceTo measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of Fiberoptic bronchoscope. | Other | The measured distance |
| formulaCalculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423 | Other | formula |
| Fiberoptic bronchoscopeThe intubation of Uniblocker under the guidance of Fiberoptic bronchoscope | Device | Fiberoptic bronchoscope |
Primary outcome
The intubation time
Time frame: 1 year
The intubation time defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until Uniblocker at the optimal position and this was done using a stopwatch.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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.
Yang Li contact
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 measured distance, formula and Fiberoptic bronchoscope 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 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: status not confirmed, as of the sponsor's last update on 9 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Li (+86-03355908500), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intubation time (time frame: 1 year). 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 9 Jan 2018.